LLY Eli Lilly and Company

166.45
-2.68  -2%
Previous Close 169.13
Open 169.88
52 Week Low 101.36
52 Week High 170.75
Market Cap $159,201,177,070
Shares 956,450,448
Float 788,868,896
Enterprise Value $177,217,364,270
Volume 2,955,378
Av. Daily Volume 3,725,784
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Baricitinib (NIAID Adaptive Treatment Trial)
COVID-19 Coronavirus
Phase 3
Phase 3
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
LY3127804
COVID-19
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Baricitinib
COVID-19
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Tanezumab
Osteoarthritis
PDUFA
PDUFA
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Tanezumab
Cancer pain
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Baricitinib
Alopecia Areata
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Solanezumab
Inherited Alzheimers Disease
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Mirikizumab
Ulcerative Colitis
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Mirikizumab
Psoriasis
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Tirzepatide
Type 2 Diabetes
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
AM0010 (PEG-IL-10) and Pembrolizumab - Cypress 1
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Lebrikizumab
Atopic Dermatitis
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Baricitinib
Systemic lupus erythematosus (SLE)
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Zagotenemab
Alzheimer's disease
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.
Mirikizumab
Crohn's disease
Phase 3
Phase 3
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
Abemaciclib - monarchE
HR+ / HER2- breast cancer
Phase 3
Phase 3
Phase 3 trial met the primary endpoint of invasive disease-free survival (IDFS) - June 16, 2020.
Lyumjev ultra rapid insulin
Diabetes
Approved
Approved
FDA Approval announced June 15, 2020.
JS016
COVID-19 antibody
Phase 1
Phase 1
Phase 1 commencement of dosing announced June 8, 2020.
LY-CoV555
COVID-19 Antibody
Phase 1
Phase 1
Phase 1 commencement of dosing announced June 1, 2020.
Taltz (Ixekizumab)
Non-radiographic axial spondyloarthritis
Approved
Approved
FDA Approval announced June 1, 2020.
CYRAMZA Ramucirumab
Non-small cell lung cancer
Approved
Approved
FDA Approval announced May 29, 2020.
Flortaucipir F 18 (Tau imaging agent)
Patients evaluated for Alzheimer's Disease
Approved
Approved
FDA Approval announced May 28, 2020.
Selpercatinib
Non-small cell lung cancer, medullary thyroid cancer and thyroid cancer.
Approved
Approved
FDA Approval announced May 8, 2020.
Taltz (ixekizumab)
Pediatric Patients with Moderate to Severe Plaque Psoriasis
Approved
Approved
FDA Approval announced March 30, 2020.
Empagliflozin
Type 1 Diabetes
CRL
CRL
CRL announced March 20, 2020.
Trulicity REWIND CV outcomes
Type 2 diabetes
Approved
Approved
FDA Approval announced February 21, 2020.
Tanezumab
Chronic low back pain
Phase 3
Phase 3
Phase 3 data released February 19, 2019. 10mg dose met primary endpoint. 5mg dose did not meet endpoint.
Glycopyrronium tosylate
Primary axillary hyperhidrosis
Approved
Approved
Approval announced June 29, 2018.
QBREXZA (glycopyrronium)
Primary palmar hyperhidrosis
Phase 2
Phase 2
Proof of concept initiation announced February 22, 2019.
Solanezumab
Inherited Alzheimer's disease
Phase 2/3
Phase 2/3
Phase 3 trial did not meet primary endpoint - February 10, 2020.
Baricitinib
Atopic dermatitis
Phase 3
Phase 3
Phase 3 BREEZE-AD5 trial met primary endpoint - January 30, 2020.
Empagliflozin, linagliptin and metformin - triple combo
Type 2 Diabetes
Approved
Approved
FDA Approval announced January 27, 2020.
Tyvyt and ALIMTA
Nonsquamous NSCLC
Phase 3
Phase 3
Phase 3 trial met primary endpoint - January 13, 2020.
LOXO-292
Medullary thyroid cancer (MTC)
Phase 3
Phase 3
Phase 3 trial initiation announced December 30, 2019.
Empagliflozin
Heart failure with preserved ejection fraction (HFpEF)
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - December 13, 2019.
Empagliflozin
Heart failure with reduced ejection fraction (HFrEF)
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - December 13, 2019.
Selpercatinib (LOXO-292)
Treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial initiation announced December 11, 2019.
LOXO-305
Refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), non-Hodgkin’s lymphomas (NHL)
Phase 1/2
Phase 1/2
Phase 1/2 presentation at ASH December 8, 2019 noted CLL 77% ORR; MCL 50% ORR.
AM0010 (PEG-IL-10) - Sequoia
Pancreatic ductal adenocarcinoma (PDAC)
Phase 3
Phase 3
Phase 3 top-line data did not meet primary endpoint - October 16, 2019.
Lasmiditan
Migraine
Approved
Approved
FDA Approval announced October 11, 2019.
Ixekizumab
Axial Spondyloarthritis
Approved
Approved
FDA Approval announced August 26, 2019.
Galcanezumab
Chronic and episodic migraine
Phase 3
Phase 3
Phase 3 trial met primary endpoint - August 5, 2019.
BAQSIMI (glucagon)
Severe hypoglycemia in people with diabetes
Approved
Approved
FDA Approval announced July 24, 2019.
Galcanezumab
Cluster headache
Approved
Approved
FDA Approval announced June 4, 2019.
Taltz (Ixekizumab) and adalimumab
Psoriatic Arthritis
Phase 3
Phase 3
Phase 3 trial met primary and key secondary endpoints - December 17, 2018.
Lanabecestat (AZD3293) - AMARANTH
Early Alzheimer's disease
Phase 3
Phase 3
Announced discontinuation of trial due to futility - June 12, 2018.
Tradjenta (linagliptin) - CARMELINA CV outcomes
Type 2 Diabetes
Phase 3
Phase 3
Phase 3 trial met primary endpoint - July 19, 2018.
Tradjenta (linagliptin) - CAROLINA CV outcomes
Type 2 Diabetes
Phase 3
Phase 3
Phase 3 trial met primary endpoint of non-inferiority.
Ramucirumab REACH-2
Hepatocellular Carcinoma
Approved
Approved
FDA approval announced May 13, 2019.
Larotrectinib (LOXO-101)
Solid tumors that harbor a TRK fusion.
Approved
Approved
FDA Approval announced November 26, 2018.
(MK-3475-189/KEYNOTE-189)
First Line Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Approved
Approved
FDA label expansion announced January 31, 2019.
LARTRUVO (olaratumab)
Soft tissue sarcoma (STS)
Phase 3
Phase 3
Phase 3 data released January 18, 2018 did not meet primary endpoint. FDA had already awarded accelerated approval.
Galcanezumab - EVOLVE-1, EVOLVE-2 and REGAIN
Migraine prevention
Approved
Approved
FDA approval announced September 27, 2018.
KEYTRUDA + chemo (KEYNOTE-021)
First-Line Nonsquamous Non-small cell lung cancer (NSCLC)
Approved
Approved
FDA approval (label expansion) announced June 5, 2018.
Baricitinib
Rheumatoid arthritis
Approved
Approved
CRL received April 14, 2017. NDA resubmitted. Approval announced for low dose only - June 1, 2018.
Abemaciclib - MONARCH 3
HR+, HER2-locoregionally recurrent or metastatic breast cancer (MBC)
Approved
Approved
Approval announced February 26, 2018.
Abemaciclib - MONARCH 1 and 2
Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer
Approved
Approved
Approved October 4, 2017.
Abemaciclib - JUNIPER
Thrid line KRAS mutation positive Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 data released October 10, 2017 - primary endpoint not met.
Taltz
Psoriatic Arthritis
Approved
Approved
Approval announced December 1, 2017.
Ramucirumab - RAINFALL
First-line gastric cancer
Phase 3
Phase 3
Phase 3 PFS data met primary endpoint but overall survival not improved. Will not seek regulatory approval.

Latest News

  1. INDIANAPOLIS, June 25, 2020 /PRNewswire/ -- A coalition of local stakeholders has established the Central Indiana Racial Equity Fund with an initial investment of more than $2.2 million to advance effective solutions to racial inequality in Indianapolis and its surrounding counties. The fund will work with organizations to support efforts to improve interactions between the Black community and local police in Indianapolis; address the disproportionate number of Black youth in the juvenile and criminal justice system by providing positive alternatives for education and employment; and increase employment, health and wealth opportunities for communities of color. 

    The fund was established by the Eli Lilly and Company Foundation, Lumina Foundation…

    INDIANAPOLIS, June 25, 2020 /PRNewswire/ -- A coalition of local stakeholders has established the Central Indiana Racial Equity Fund with an initial investment of more than $2.2 million to advance effective solutions to racial inequality in Indianapolis and its surrounding counties. The fund will work with organizations to support efforts to improve interactions between the Black community and local police in Indianapolis; address the disproportionate number of Black youth in the juvenile and criminal justice system by providing positive alternatives for education and employment; and increase employment, health and wealth opportunities for communities of color. 

    The fund was established by the Eli Lilly and Company Foundation, Lumina Foundation and Central Indiana Community Foundation, with contributions from the Anthem Foundation, Buckingham Foundation, Dorsey Foundation, Rick Fuson and Karen Ferguson Fuson, Marianne Glick and Mike Woods, Glick Philanthropies, Herbert Simon Family Foundation, High Alpha, The Indianapolis Foundation, Indianapolis Power & Light Company, Lilly Endowment Inc., and Pacers Foundation.

    The Central Indiana Community Foundation (CICF) will also serve as the fiscal agent and project manager. The intent is to grow the fund with additional commitments from companies and other organizations across Indiana.

    "Lilly and the Lilly Foundation are committed to action in addressing the systemic injustices in America that disadvantage people of color, with a special responsibility to Indianapolis, home of our headquarters for 144 years," said Tiffany Benjamin, president of the Lilly Foundation. "This is the first distribution of the Lilly Foundation's $25 million commitment over five years to decrease the burden of racial injustice on communities of color, including health, education and economic inequalities."

    The Central Indiana Racial Equity Fund will support organizations focused on having difficult conversations about Indiana's and the Nation's complicated past; building additional capacity within the nonprofit sector to address issues of racial inequity, in particular relating to the criminal justice system; and advancing effective, data-driven solutions at the local level.

    The fund will be led by a community-driven, multigenerational steering committee:

    • Darryl Lockett, executive director, Kennedy King Memorial Initiative
    • Jasmin-Shaheed Young, president and CEO, RISE Indy
    • Jordan Maitland, regulatory consultant, Eli Lilly and Company
    • Kai Wright, executive director, Voices Corporation
    • Nick Ison, corporate giving manager, Goodwill of Central and Southern Indiana
    • Valerie Davis, community ambassador, Near Eastside neighborhood, Central Indiana Community Foundation
    • William Shrewsberry, founder, Shrewsberry & Associates LLC

    "Lumina Foundation's work has long been driven by our 'equity imperative,' a focus on justice for Black, Hispanic, and Native American students that we build into all of our efforts to increase the nation's educational attainment," said Timothy P. Robinson, assistant vice president, operations, and grants administration at Lumina. "To strengthen those efforts, we have forged a new commitment to what we call Equity and Justice Intelligence – our capacity to address diversity, inclusion and racial justice in all of our work."

    "In 2018, CICF changed its mission and made the generational commitment to dismantle systemic racism in our community," said Pamela Ross, vice president of opportunity, equity and inclusion at CICF. "We knew then and we know now that we cannot do this work alone. Collaborating with our philanthropic and corporate leaders in our community to create this fund is a huge step forward in our fight for creating a community where everyone has an opportunity to thrive—no matter place, race or identity."

    Learn more at racialequity.fund.

    About Eli Lilly and Company Foundation

    Established in 1968, the Eli Lilly and Company Foundation is a private, tax-exempt organization that makes strategic and philanthropic investments consistent with Eli Lilly and Company's purpose of making life better. The Lilly Foundation's areas of focus include improving health for people living in communities with limited resources, strengthening communities and improving education opportunities for children living in underserved neighborhoods. In 2020, the Lilly Foundation established a new area of focus to address racial inequities in Indianapolis, and nationally.

    About Lumina Foundation

    Lumina Foundation is an independent, private foundation in Indianapolis that is committed to making opportunities for learning beyond high school available to all. We envision a system that is easy to navigate, delivers fair results, and meets the nation's need for talent through a broad range of credentials. Our goal is to prepare people for informed citizenship and for success in a global economy.

    About Central Indiana Community Foundation

    Central Indiana Community Foundation (CICF) is an $850 million public foundation working to mobilize people, ideas and investments to make this a community where all individuals have equitable opportunity to reach their full potential–no matter place, race or identity. CICF was established in 1997 as a partnership between The Indianapolis Foundation, serving Marion County since 1916, and Hamilton County Community Foundation, serving Hamilton County since 1991. For more information about CICF, visit cicf.org, or call 317.634.2423.

    About Eli Lilly and Company

    Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and https://www.lilly.com/news. C-LLY

    Refer to:          

    David Marbaugh; ; +1-317-489-7109



    Ben Snyder; ; +1-317-634-2423

     

    Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/central-indiana-racial-equity-fund-launches-with-more-than-2-2-million-in-initial-commitments-301083649.html

    SOURCE Eli Lilly and Company

    View Full Article Hide Full Article
  2. INDIANAPOLIS, June 24, 2020 /PRNewswire/ -- About 34 million Americans live with diabetes, and some are at risk of low blood sugar and very low blood sugar emergencies (severe hypoglycemia).1 That is why Eli Lilly and Company (NYSE:LLY) launched a new initiative today, to raise awareness about being prepared for these unpredictable conditions. With Know Before the Low, Lilly is encouraging people with diabetes to recognize and share their signs and symptoms of low blood sugar with their support network, while also being prepared with a rescue plan in case of a very low blood sugar emergency. Singer/songwriter and Lilly Diabetes Ambassador Crystal Bowersox is helping to kick off the program by sharing her journey and teaching others about the…

    INDIANAPOLIS, June 24, 2020 /PRNewswire/ -- About 34 million Americans live with diabetes, and some are at risk of low blood sugar and very low blood sugar emergencies (severe hypoglycemia).1 That is why Eli Lilly and Company (NYSE:LLY) launched a new initiative today, to raise awareness about being prepared for these unpredictable conditions. With Know Before the Low, Lilly is encouraging people with diabetes to recognize and share their signs and symptoms of low blood sugar with their support network, while also being prepared with a rescue plan in case of a very low blood sugar emergency. Singer/songwriter and Lilly Diabetes Ambassador Crystal Bowersox is helping to kick off the program by sharing her journey and teaching others about the importance of sharing their rescue plan with their own support network.

    Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8688551-know-before-the-low/

    Know Before the Low

    "I learned early on that one of the essential elements of managing my diabetes is to always have a plan in place for low blood sugar," explained Bowersox, who has lived with type 1 diabetes since she was six years old. "This means ensuring those around me are ready and able to help in case of a very low blood sugar emergency. As a touring musician, my family or friends may not always be around. Because of this, I'm constantly thinking through different scenarios like teaching my crew what to do, and knowing I have a network of people who are empowered to help me stay safe and healthy in my journey."

    Managing diabetes, including low blood sugar events, can trigger people to feel stressed, frustrated or overwhelmed.2 People with diabetes can share their rescue plan with their support network as one way to feel more confident that they are prepared in the event of a very low blood sugar emergency.

    By visiting KnowBeforeTheLow.com, people with diabetes and their support network can access easy-to-understand information about recognizing the signs and symptoms of mild, moderate, and severe low blood sugar, when a very low blood sugar emergency can happen, and how to be prepared with a rescue plan. They will also find a helpful conversation starter and tip list to help navigate conversations with their diabetes healthcare team to create preparedness and rescue plans for these conditions. These resources are designed to help people with diabetes gain the tools to effectively educate their support network about stepping into action during a very low blood sugar emergency.

    "For people with diabetes, balancing the highs and lows of blood sugar is part of everyday life. Even with careful monitoring, planning, and preparation, blood sugar can sometimes go low. In the event of a very low blood sugar emergency, the person can become unconscious or unable to treat themselves, requiring the help of someone else for treatment3," said Dr. Gregory Dodell, endocrinologist and member of the American Association of Clinical Endocrinologists (AACE). "When a very low blood sugar emergency happens, people with diabetes need someone around them to act immediately and effectively. That's why it's critical for people with diabetes to have a rescue plan and then educate and empower their support network about their rescue plan and when to put it into action."

    For more information about low blood sugar and very low blood sugar emergencies, please visit KnowBeforeTheLow.com.

    About Know Before the Low

    Know Before the Low is an educational initiative developed by Lilly Diabetes to foster a conversation among the diabetes community, their support network, and diabetes healthcare team. This open communication will help to educate people about the various stages of low blood sugar and how to be prepared with a rescue plan and when to put it into action.

    At KnowBeforeTheLow.com, people with diabetes and their support network can access easy-to-understand information about the signs and symptoms of low blood sugar, when a very low blood sugar emergency can happen, and how to empower support networks during a very low blood sugar emergency. For more information, visit KnowBeforeTheLow.com.

    About Diabetes

    Approximately 34 million Americans1 (just over 1 in 10) and an estimated 463 million adults worldwide have diabetes.4 Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone.1 Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.

    About Lilly Diabetes

    Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

    About Eli Lilly and Company

    Lilly is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels. P-LLY

    For media inquiries, please contact:

    DeShong Perry-Smitherman

    Eli Lilly and Company

     

    (317) 719- 4612

    PP-LD-US-2163 06/2020 ©Lilly USA, LLC 2020. All rights reserved.

    Know Before the Low™ is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

    1 Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services; 2020.

    2 American Diabetes Association, Understanding diabetes and mental health. Website: https://www.diabetes.org/diabetes/mental-health

    3 American Association of Diabetes Care & Education Specialists, Hypoglycemia. Website: https://www.diabeteseducator.org/docs/default-source/living-with-diabetes/tip-sheets/Hypoglycemia/hypoglycemia-symptom-and-treatment-tip-sheet.pdf?sfvrsn=0

    4 International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes Federation, 2019. Available at: http://diabetesatlas.org.

     Crystal Bowersox

     

    Eli_Lilly_and_Company_logo

     

    Cision View original content:http://www.prnewswire.com/news-releases/lilly-launches-program-about-what-people-with-diabetes-should-know-before-the-low-301082517.html

    SOURCE Eli Lilly and Company

    View Full Article Hide Full Article
  3. RIDGEFIELD, Conn. and INDIANAPOLIS, June 19, 2020 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced full results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to exercise ability and symptom improvement with Jardiance® (empagliflozin) in adults with chronic heart failure with reduced and preserved ejection fraction, respectively. The results were presented through the European Society of Cardiology's HFA Discoveries program.

    "The EMPERIAL trials, which assessed exercise ability, are one piece of our clinical program evaluating the potential of Jardiance in treating heart failure, a condition affecting 60 million people worldwide," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president…

    RIDGEFIELD, Conn. and INDIANAPOLIS, June 19, 2020 /PRNewswire/ -- Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced full results from the EMPERIAL-Reduced and EMPERIAL-Preserved trials related to exercise ability and symptom improvement with Jardiance® (empagliflozin) in adults with chronic heart failure with reduced and preserved ejection fraction, respectively. The results were presented through the European Society of Cardiology's HFA Discoveries program.

    "The EMPERIAL trials, which assessed exercise ability, are one piece of our clinical program evaluating the potential of Jardiance in treating heart failure, a condition affecting 60 million people worldwide," said Mohamed Eid, M.D., M.P.H., M.H.A., vice president, Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine, Boehringer Ingelheim Pharmaceuticals, Inc. "At the center of our heart failure program are the ongoing EMPEROR trials, which are investigating outcomes including cardiovascular death, hospitalization for heart failure and quality of life. We look forward to sharing results from the EMPEROR-Reduced trial this year for people with heart failure and reduced ejection fraction."

    As previously reported, the EMPERIAL trials showed no significant difference in change from baseline to week 12 in exercise ability with Jardiance versus placebo, as measured by the six-minute walk test, which was the primary endpoint of the studies. In EMPERIAL-Reduced, the median six-minute walk test increased by 13.5 meters with Jardiance compared with 18.0 meters with placebo. In EMPERIAL-Preserved the increase was 10.0 meters with Jardiance versus 5.0 meters with placebo.

    Exploratory analyses of EMPERIAL-Reduced suggest Jardiance was associated with improvements in quality of life. Researchers employed the Kansas City Cardiomyopathy Questionnaire (KCCQ), a widely used patient-reported measure of quality of life for heart failure. Mean improvement in total symptom score (TSS) of the KCCQ from baseline to week 12 was 4.55 points higher for Jardiance compared with placebo. Additionally, a greater proportion of those taking Jardiance had improvements compared with placebo in KCCQ-TSS of at least 5 and at least 8 points – two pre-specified thresholds that were identified to measure clinically meaningful response to treatment. Similar exploratory analyses of EMPERIAL-Preserved did not indicate improvements with Jardiance versus placebo in these same measures for adults with heart failure with preserved ejection fraction.

    The EMPERIAL trials included people with and without diabetes. The safety profile in those with diabetes was similar to the known safety profile of Jardiance for adults with type 2 diabetes. In those without diabetes, no new safety events were identified, and the frequency of hypoglycemic events with Jardiance in this population was similar to that of placebo. Overall, in both trials, there was no notable difference between Jardiance and placebo in the frequency of adverse events, including those leading to discontinuation of study medication, and no new safety concerns were identified.

    Other heart failure guideline-recommended therapies have shown divergent results between studies examining clinical outcomes and symptom improvement, with some showing improvements in outcomes such as mortality, but neutral or inconsistent results in exercise ability and patient-reported outcomes.

    "Cardio-renal-metabolic conditions, a group of disorders affecting the heart, kidneys and endocrine systems, are becoming increasingly common," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly. "Our EMPOWER clinical trial program, which is exploring the impact of Jardiance across the spectrum of cardio-renal-metabolic conditions, is one of the broadest and most comprehensive of any SGLT2 inhibitor. Through our research we aim to contribute new knowledge that can help improve outcomes for the millions of people affected by these conditions."

    About EMPERIAL

    EMPERIAL consisted of two Phase III randomized, double-blind trials in adults with or without diabetes. The trials evaluated the effect of 12 weeks' treatment of once-daily Jardiance 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* The primary endpoint was measured by the six-minute walk test, a common measure of exercise ability.

    • EMPERIAL-Preserved [NCT03448406]: investigated Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looked at a functional endpoint — how far patients can walk in six minutes — and at heart failure symptoms.
      • Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
      • Number of patients enrolled: 315
      • Completed: October 9, 2019
    • EMPERIAL-Reduced [NCT03448419]: investigated Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looked at a functional endpoint — how far patients can walk in six minutes — and at heart failure symptoms.
      • Primary endpoint: Change from baseline to week 12 in exercise ability as measured by the distance walked in six minutes
      • Number of patients enrolled: 312
      • Completed: October 7, 2019

    *Ejection fraction is a measurement expressed as a percentage of the amount of blood that leaves the heart each time it contracts, related to the total blood volume of the heart chambers. During each heartbeat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood.

    HFpEF occurs when the heart muscle contracts normally but the ventricle muscles are stiff. They do not relax as they should when the ventricle fills with blood, so less blood can enter the heart compared to a normally functioning heart.

    HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.

    Both HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling and fatigue.

    About EMPOWER

    The EMPOWER program reinforces the long-term commitment of Boehringer Ingelheim and Eli Lilly and Company to evaluate the potential of Jardiance to improve outcomes for adults living with cardio-renal-metabolic conditions. EMPOWER is one of the largest clinical trial programs for an SGLT2 inhibitor to date with more than 13,000 adults worldwide. 

    The development program encompasses:

    • EMPEROR-Reduced, in adults with chronic heart failure with reduced ejection fraction to reduce the risk of cardiovascular death and hospitalization due to heart failure
    • EMPEROR-Preserved, in adults with chronic heart failure with preserved ejection fraction to reduce the risk of cardiovascular death and hospitalization due to heart failure
    • EMPULSE, in adults hospitalized for acute heart failure to improve clinical and patient reported outcomes
    • EMPACT-MI, to improve outcomes and prevent heart failure in adults with and without diabetes who have had an acute myocardial infarction
    • EMPA-KIDNEY, in adults with established chronic kidney disease to reduce the progression of kidney disease and the occurrence of cardiovascular death
    • EMPERIAL-Reduced, in adults with chronic heart failure with reduced ejection fraction to improve exercise ability and patient reported outcomes
    • EMPERIAL-Preserved, in adults with chronic heart failure with preserved ejection fraction to improve exercise ability and patient reported outcomes
    • EMPA-REG OUTCOME®, in adults with type 2 diabetes and established cardiovascular disease to reduce the risk of major adverse cardiovascular events, including cardiovascular death
    • EMPRISE, assessing comparative efficacy, safety, healthcare resource utilization and costs of care in routine clinical care in adult patients with diabetes

    About Heart Failure

    Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot supply adequate circulation to meet the body's demands for oxygenated blood or to do so requires increased blood volume leading to fluid accumulation (congestion) in the lungs and peripheral tissues. It is a widespread condition affecting 60 million people worldwide and expected to increase as the population ages. Heart failure is highly prevalent in people with diabetes; however, approximately half of all people with heart failure do not have diabetes. 

    The Jardiance heart failure program was initiated based on data from the EMPA-REG OUTCOME trial, which assessed the effect of Jardiance added to standard of care compared with placebo added to standard of care. EMPA-REG OUTCOME was the first SGLT2 inhibitor trial to show a relative risk reduction in cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. This population was comprised of more than 45% of adults with a prior myocardial infarction.

    About Cardio-Renal-Metabolic Conditions

    Cardio-renal-metabolic conditions are a group of interconnected disorders affecting the heart, kidneys and endocrine system. In aggregate, these conditions are the leading cause of deaths worldwide, accounting for up to 20 million deaths annually. Conditions within this group include coronary artery disease, heart failure, chronic kidney disease and type 2 diabetes, among many others.

    Emerging science on the link between the cardiorenal and metabolic systems supports taking a multidisciplinary approach toward diagnostic, preventive and therapeutic strategies for people living with these conditions. We remain committed to developing treatments with broad cardio-renal-metabolic effects, which may help improve outcomes for people with serious chronic conditions such as these.

    What is JARDIANCE? (www.jardiance.com)

    JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

    JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

    JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

    IMPORTANT SAFETY INFORMATION

    Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.

    Do not take JARDIANCE if you have severe kidney problems or are on dialysis.

    JARDIANCE can cause serious side effects, including:

    • Dehydration. JARDIANCE can cause some people to have dehydration (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up.

    You may be at a higher risk of dehydration if you:

      • have low blood pressure
      • take medicines to lower your blood pressure, including water pills (diuretics)
      • are on a low salt diet
      • have kidney problems
      • are 65 years of age or older
    • Vaginal yeast infection. Women who take JARDIANCE may get vaginal yeast infections. Talk to your doctor if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
    • Yeast infection of the penis. Men who take JARDIANCE may get a yeast infection of the skin around the penis, especially uncircumcised males and those with chronic infections. Talk to your doctor if you experience redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around penis.
    • Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition and may need to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE. Stop taking JARDIANCE and call your doctor right away if you get any of the following symptoms, and if possible, check for ketones in your urine:
    • nausea                  
    • vomiting
    • stomach-area (abdominal) pain
    • tiredness
    • trouble breathing
    • Kidney problems. Sudden kidney injury has happened in people taking JARDIANCE. Talk to your doctor right away if you reduce the amount you eat or drink, or if you lose liquids; for example, from vomiting, diarrhea, or being in the sun too long.
    • Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your doctor if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
    • Low blood sugar (hypoglycemia): If you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include:
    • headache
    • drowsiness
    • weakness
    • dizziness
    • confusion
    • irritability
    • hunger
    • fast heartbeat
    • sweating
    • shaking or feeling jittery
    • Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).
    • Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to JARDIANCE may include:
      • swelling of your face, lips, throat and other areas of your skin
      • difficulty with swallowing or breathing
      • raised, red areas on your skin (hives)

        If you have any of these symptoms, stop taking JARDIANCE and contact your doctor or go to the nearest emergency room right away.



    • Increased fats in your blood (cholesterol).

    The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females.

    These are not all the possible side effects of JARDIANCE. For more information, ask your doctor or pharmacist.

    Before taking JARDIANCE, tell your doctor if you:

    • have kidney problems. Your doctor may do blood tests to check your kidneys before and during your treatment with JARDIANCE
    • have liver problems
    • have a history of urinary tract infections or problems with urination
    • are going to have surgery. Your doctor may stop your JARDIANCE before you have surgery. Talk to your doctor if you are having surgery about when to stop taking JARDIANCE and when to start it again
    • are eating less or there is a change in your diet
    • have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas
    • drink alcohol very often, or drink a lot of alcohol in the short term ("binge" drinking)
    • have any other medical conditions
    • are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with JARDIANCE
    • are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. Do not breastfeed while taking JARDIANCE

         Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take water pills (diuretics) or medicines that can lower your blood sugar, such as insulin.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    For more information, please see Prescribing Information and Medication Guide.

    CL-JAR-100057 01.27.2020

    Boehringer Ingelheim and Eli Lilly and Company

    In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance that centers on compounds representing several of the largest diabetes treatment classes. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributing to the alliance. The alliance leverages the strengths of two of the world's leading pharmaceutical companies to focus on patient needs. By joining forces, the companies demonstrate their commitment, not only to the care of people with diabetes, but also to investigating the potential to address areas of unmet medical need. Clinical trials have been initiated to evaluate the impact of Jardiance on people living with heart failure or chronic kidney disease.

    About Boehringer Ingelheim

    Making new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

    As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

    We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

    Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies.  In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.



    Boehringer Ingelheim is committed to improving lives and strengthening our communities. Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

    For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

    About Lilly Diabetes

    Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

    About Eli Lilly and Company

    Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and newsroom.lilly.com/social-channels

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Jardiance and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that Jardiance will receive additional regulatory approvals. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

    Jardiance® and EMPA-REG OUTCOME® are registered trademarks of Boehringer Ingelheim.

    P-LLY

    MPR-US-101285

    CONTACT:

    Jennifer Forsyth

    Director, Public Relations

    Boehringer Ingelheim Pharmaceuticals, Inc.

    Email:

    Phone: (203) 791-5889

    Stephan Thalen 

    Global Business Communications

    Lilly Diabetes and Lilly USA

    Email:  

    Phone: (317) 903-5640

    (PRNewsfoto/Boehringer Ingelheim)

     

    Eli Lilly and Company logo. (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/full-results-from-emperial-exercise-ability-trials-presented-301080354.html

    SOURCE Eli Lilly and Company

    View Full Article Hide Full Article
  4. INDIANAPOLIS, June 17, 2020 /PRNewswire/ -- Emgality® (galcanezumab-gnlm) reduces total pain burden in a recent analysis of patients with episodic and chronic migraine. Total pain burden is a patient-centric measure that combines the monthly frequency, duration, and pain severity of migraine. Additionally, total pain burden demonstrated significant associations with patient functioning and quality of life. Eli Lilly and Company's (NYSE:LLY) Emgality is the first and only migraine preventive CGRP medication to be assessed in this manner, providing a more complete picture of how Emgality reduced frequency, duration, and severity of migraine pain. These results were presented virtually at the 62nd American Headache Society Congress during National…

    INDIANAPOLIS, June 17, 2020 /PRNewswire/ -- Emgality® (galcanezumab-gnlm) reduces total pain burden in a recent analysis of patients with episodic and chronic migraine. Total pain burden is a patient-centric measure that combines the monthly frequency, duration, and pain severity of migraine. Additionally, total pain burden demonstrated significant associations with patient functioning and quality of life. Eli Lilly and Company's (NYSE:LLY) Emgality is the first and only migraine preventive CGRP medication to be assessed in this manner, providing a more complete picture of how Emgality reduced frequency, duration, and severity of migraine pain. These results were presented virtually at the 62nd American Headache Society Congress during National Migraine Awareness Month and at the 72nd American Academy of Neurology Annual Meeting in April (click here for the abstract).

    "Total pain burden moves beyond the current and somewhat limited approach for describing migraine pain," said Gudarz Davar, M.D., vice president, neurology development, Lilly Bio-Medicines. "We're delighted that Emgality reduced the combined impact of migraine frequency, duration, and pain severity. We believe that viewing migraine through the lens of total pain burden provides a more holistic approach for people with migraine and doctors to discuss the personal pain experience."

    This post hoc analysis of Emgality versus placebo used data from three randomized, double-blind studies in patients with episodic migraine (two pooled six-month studies – EVOLVE-1 and EVOLVE-2; Emgality n=435, placebo n=872) and chronic migraine (one three-month study – REGAIN; Emgality n=273, placebo n=535). Patients reported their headache frequency, duration, and severity using an electronic diary. Monthly total pain burden was calculated as severity-weighted duration by multiplying hours of migraine recorded and pain severity (0=none, 1=mild, 2=moderate, 3=severe) for each migraine day and summing these composite measurements over the migraine days in a month.

    The mean change from baseline in monthly total pain burden was compared between Emgality and placebo groups. Patients on Emgality experienced statistically fewer severity-weighted hours of pain than at baseline at each month compared with patients on placebo (p<0.0001 for each comparison). In episodic migraine, patients on Emgality experienced 68.6 fewer severity-weighted hours of pain per month on average than at baseline and compared to those on placebo who experienced 36.2 fewer hours (mean difference = 32.3 fewer hours, 95% CI: 24.2 to 40.3). In chronic migraine, patients on Emgality experienced 102.6 fewer severity-weighted hours of pain per month on average than at baseline and compared to those on placebo who experienced 44.4 fewer hours of pain than at baseline (mean difference = 58.2 severity-weighted hours, 95% CI: 37.1 to 79.3).  

    "The impact of migraine is profound, and individualized management goes beyond how many days per month a person experiences migraine. Total pain burden serves as a more comprehensive measure and provides a deeper understanding for us and our patients to describe their pain," said Jessica Ailani, M.D., Director, MedStar Georgetown Headache Center, Professor of Clinical Neurology, Georgetown University Hospital. "As a clinician, I'm pleased that Emgality may help my patients achieve their preventive treatment goals. I am excited the results of this study show a positive impact on the cumulative burden of frequency, duration, and pain severity of migraine." 

    For over 25 years, Lilly has been committed to helping people affected by headache disorders, investigating more than a dozen different compounds for the treatment of migraine and cluster headache. These research programs have accelerated our understanding of these diseases and empowered us to offer new and novel medications to patients and healthcare professionals.

    About Emgality

    Emgality is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP) and was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. Emgality is the only CGRP monoclonal antibody with response rates in the episodic migraine headache population on ≥50%, ≥75% and 100% reduction from baseline in monthly migraine headache days over Months 1 to 6 included in its Full Prescribing Information. In June 2019, Emgality was approved by the FDA for the treatment of episodic cluster headache in adults.

    Indications and Usage for Emgality (galcanezumab-gnlm) 120 mg Injection

    Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated in adults for the:

    • preventive treatment of migraine
    • treatment of episodic cluster headache

    Important Safety Information

    Contraindications

    Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

    Warnings and Precautions

    Hypersensitivity Reactions

    Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.

    Adverse Reactions

    The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

    Please see Full Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the device.

    GZ HCP ISI 10DEC2019

    About Migraine

    Migraine is a neurologic disease characterized by recurrent episodes of moderate-to-severe headache accompanied by other symptoms including nausea, sensitivity to light and sensitivity to sound. More than 30 million American adults have migraine, with three times more women affected by migraine compared to men. According to the Medical Expenditures Panel Survey, total annual healthcare costs associated with migraine are estimated to be as high as $56 billion annually in the United States, yet it remains under-recognized and under-treated.

    About Lilly's Commitment to Headache Disorders

    For over 25 years, Lilly has been committed to helping people affected by headache disorders, investigating more than a dozen different compounds for the treatment of migraine and cluster headache. These research programs have accelerated our understanding of these diseases and furthered the advancement of Emgality, approved by the U.S. Food and Drug Administration for the preventive treatment of migraine in adults and the treatment of episodic cluster headache in adults. Our goal is to apply our combined clinical, academic and professional experience to build a research portfolio that delivers comprehensive solutions and addresses the needs of people affected by these disabling neurologic diseases.

    About Eli Lilly and Company

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Emgality (galcanezumab-gnlm) as a preventive treatment for patients with migraine and as a treatment for patients with episodic cluster headache, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that Emgality will receive any additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

    Refer to:

    Jen Dial; ; 317-220-1172 (Lilly Bio-Medicines)



    Kevin Hern; ; 317-277-1838 (Investor Relations)   

     

    Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/emgality-demonstrates-reduction-in-frequency-duration-and-pain-severity-in-patients-with-episodic-and-chronic-migraine-301078159.html

    SOURCE Eli Lilly and Company

    View Full Article Hide Full Article
  5. INDIANAPOLIS, June 16, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) announced today that less than 30 percent of people with migraine are taking a recommended prescription medication, highlighting the need for improvement in migraine care. These data are from the initial cohort of the OVERCOME (Observational Survey of the Epidemiology, Treatment and Care of Migraine) study, which collected responses from more than 21,000 people living with migraine. The OVERCOME study aims to further understand the burden of migraine and stigma experienced by people living with the disease, identify barriers to the appropriate treatment of migraine and assess how the introduction of novel treatment options may influence delivery of migraine care and…

    INDIANAPOLIS, June 16, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) announced today that less than 30 percent of people with migraine are taking a recommended prescription medication, highlighting the need for improvement in migraine care. These data are from the initial cohort of the OVERCOME (Observational Survey of the Epidemiology, Treatment and Care of Migraine) study, which collected responses from more than 21,000 people living with migraine. The OVERCOME study aims to further understand the burden of migraine and stigma experienced by people living with the disease, identify barriers to the appropriate treatment of migraine and assess how the introduction of novel treatment options may influence delivery of migraine care and outcomes. The results were shared during the American Headache Society's 2020 Virtual Annual Scientific Meeting.

    "For millions of people living with migraine, the journey to an appropriate treatment program is fraught with gaps," said Susan Hutchinson, M.D., Orange County Migraine and Headache Center, Irvine, CA and scientific advisor to the OVERCOME study. "There are a variety of reasons at play, but it begins with the fact that many may not realize what they are experiencing is a migraine and not just 'another bad headache.' By increasing understanding of this disease, both among the public and with healthcare providers, we can improve the chances a person living with migraine will take the important step of receiving a diagnosis and ultimately, receive appropriate treatment."  

    Using data from OVERCOME, the authors assessed the proportion of people living with migraine and migraine-related disability - as measured by the Migraine Disability Assessment Scale (MIDAS) - who completed three critical steps in migraine management: 1) actively sought care with a healthcare professional, 2) received a migraine diagnosis, and 3) took a recommended prescription medication1. The objectives were to assess how many respondents completed each step and to understand migraine-related characteristics such as migraine pain severity and related disability, sociodemographic features and where respondents sought care for their migraine.

    Among OVERCOME respondents with migraine who may benefit from acute prescription medication and experienced at least mild migraine-related disability (MIDAS>6) (n=12,212), 63 percent sought care (n=7,695) and of those, 75 percent were diagnosed with migraine (n=5,802). Within the diagnosed population, only 59 percent took a recommended acute prescription medication (n=3,401). Overall, only 28 percent of the population completed all three steps to appropriate care.

    Among OVERCOME respondents who were candidates for a preventive medication (n=5,873), which includes people who experienced four or more migraine headache days per month and moderate or severe migraine-related disability (MIDAS >11), 69 percent sought care (n=4,053) and of those, 79 percent received a migraine diagnosis (n=3,218). Of those who sought care and received a diagnosis, only 28 percent took a preventive medication for migraine (n=902). Overall, only 15 percent of this population completed all three steps to appropriate care.

    "Even in light of recent new treatment options in the field of migraine, we still face an uphill battle as too many continue to be underserved," said Robert E. Shapiro, M.D., Department of Neurological Sciences, Larner College of Medicine, University of Vermont and scientific advisor to the OVERCOME study. "An important aspect of migraine care that is truly diminished and may contribute to these findings is the stigma felt by many living with the disease. A person's reluctance to seek care or take medication for their migraine can be rooted in the fear of how a friend, employer, or even a loved one may view them for doing so."

    For both populations, possessing health insurance and higher levels of migraine-related disability increased the likelihood that respondents would complete all three steps. Another common theme across both populations was approximately 10 percent of respondents sought care in an emergency room, urgent care or retail clinic setting only and as a result, were unlikely to receive an accurate diagnosis or take a recommended medication.

    "The OVERCOME study provides a snapshot into the current state of migraine in America, while reminding us there is much work to be done," said Eric Pearlman, M.D., Ph.D., senior medical director, U.S. neuroscience, Eli Lilly and Company. "We are in a golden era for migraine care with the introduction of new therapeutic options for both the acute and preventive treatment of the disease, but if we don't address the need for better education, less stigma and improved access to care, we are falling short."

    About the OVERCOME Study

    The Observational Survey of the Epidemiology, Treatment and Care of Migraine (OVERCOME) study aims to further understand the burden of migraine and stigma experienced by people living with the disease, identify barriers to the appropriate treatment of migraine and assess how the introduction of novel treatment options may influence delivery of migraine care and outcomes.

    The OVERCOME study is a prospective, web-based patient survey designed to follow U.S. population samples with migraine for two years following their enrollment. The first population sample of 21,143 began enrollment in 2018. In parallel to this population sample, the OVERCOME study also included 10,000 people who did not have migraine, providing a unique perspective about how migraine is perceived by those who do not have the disease. The second population sample of 20,782 with migraine was initiated in late 2019.

    About the OVERCOME Scientific Advisory Board

    The OVERCOME study is being conducted by Kantar on behalf of Eli Lilly and Company with expert guidance provided by some of the leading voices in migraine research today, including:

    • Richard B. Lipton (Study Chair), M.D., Department of Neurology, Albert Einstein College of Medicine and Director, Montefiore Headache Center, Montefiore Health System
    • Sait Ashina, M.D., Department of Neurology and Department of Anesthesia, Critical Care and Pain Medicine, and Harvard Medical School, Beth Israel Deaconess Medical Center
    • Dawn C. Buse, Ph.D., Department of Neurology, Albert Einstein College of Medicine, Clinical Health Psychology Doctoral Program of the Ferkauf Graduate School of Psychology, Yeshiva University
    • Susan Hutchinson, M.D., Orange County Migraine and Headache Center
    • Michael L. Reed, Ph.D., President, Vedanta Research
    • Robert E. Shapiro, M.D., Department of Neurological Sciences, Larner College of Medicine, University of Vermont

    About Eli Lilly and Company

    Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve upon the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/newsroom/social-channels.  P-LLY

    1 Recommended medications refer to those with established/probable efficacy as identified by the American Academy of Neurology (AAN)/American Headache Society (AHS) guidelines (Silberstein SD, et al. Neurology. 2012; 78:1337-1345) and the AHS position statement regarding new migraine treatments (American Headache Society. Headache. 2019; 59:1-18).

    Refer to: 

    Jen Dial; ; 317-220-1172 (Lilly Bio-Medicines)



    Kevin Hern; ; 317-277-1838 (Investor Relations)     

     

    Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/lillys-overcome-study-reveals-less-than-30-percent-of-people-living-with-migraine-take-recommended-prescription-medications-301077182.html

    SOURCE Eli Lilly and Company

    View Full Article Hide Full Article
View All Eli Lilly and Company News