FGEN FibroGen Inc

43.23
+0.17  (+0%)
Previous Close 43.06
Open 42.57
52 Week Low 22.65
52 Week High 51.56
Market Cap $3,934,393,339
Shares 91,010,718
Float 79,572,805
Enterprise Value $3,288,663,339
Volume 1,752,339
Av. Daily Volume 745,784
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Upcoming Catalysts

Drug Stage Catalyst Date
Roxadustat
Anaemia in Chronic Kidney Disease
PDUFA
PDUFA
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Roxadustat
Myelodysplastic syndromes (MDS)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Pamrevlumab (FG-3019) - ZEPHYRUS
Idiopathic pulmonary fibrosis
Phase 3
Phase 3
Phase 3 trial initiation announced July 22, 2019. Second Phase 3 trial initiation announced December 22, 2020.
Roxadustat
Chemotherapy-induced anemia (CIA)
Phase 2
Phase 2
Phase 2 trial initiation announced September 26, 2019.
Pamrevlumab
Duchenne muscular dystrophy
Phase 3
Phase 3
Phase 3 commencement of enrollment announced August 10, 2020.
Pamrevlumab (LAPIS)
Pancreatic cancer
Phase 3
Phase 3
Phase 3 initiation of dosing announced October 23, 2019.
Pamrevlumab
COVID-19
Phase 2
Phase 2
Phase 2 commencement of enrolment announced June 23, 2020.
Pamrevlumab - Borea
COVID-19
Phase 2/3
Phase 2/3
Phase 2/3 commencement of enrolment in Italy trial announced June 8, 2020.

Latest News

  1. SAN FRANCISCO, Dec. 22, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced dosing of the first patient in the ZEPHYRUS-2 Phase 3 clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and fatal lung disease.

    "Today, treatment for IPF is aimed at relieving symptoms and slowing disease progression, and disease-modifying treatment options are urgently needed," said Elias Kouchakji, M.D., Senior Vice President, Clinical Development and Drug Safety. "We are excited to advance the Phase 3 clinical development program for pamrevlumab, a first-in-class antibody which represents a novel approach to the treatment of IPF, a disease with survival rates comparable to those of some…

    SAN FRANCISCO, Dec. 22, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced dosing of the first patient in the ZEPHYRUS-2 Phase 3 clinical study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF), a chronic, progressive, and fatal lung disease.

    "Today, treatment for IPF is aimed at relieving symptoms and slowing disease progression, and disease-modifying treatment options are urgently needed," said Elias Kouchakji, M.D., Senior Vice President, Clinical Development and Drug Safety. "We are excited to advance the Phase 3 clinical development program for pamrevlumab, a first-in-class antibody which represents a novel approach to the treatment of IPF, a disease with survival rates comparable to those of some of the deadliest cancers."

    ZEPHYRUS-2 is a 52-week randomized, double-blind, placebo-controlled, multi-center Phase 3 trial designed to evaluate the efficacy and safety of pamrevlumab in subjects with IPF who were previously treated with an approved therapy but who discontinued that therapy. 

    The primary endpoint of the study is disease progression defined as a change from baseline in forced vital capacity (FVC) percent predicted decline ≥10% or death. Secondary endpoints include change in quantitative lung fibrosis (QLF) and patient-reported outcomes. Approximately 340 subjects will be enrolled into the global study. Subjects who complete the 52-week study may be eligible for rollover into a separate study offering open-label, extension treatment with pamrevlumab. For more information about ZEPHYRUS-2 please visit www.clinicaltrials.gov (NCT04419558).

    "The initiation of our second Phase 3 study of pamrevlumab for IPF furthers our research on the clinical benefits of inhibiting connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders," said Mark Eisner, M.D, M.P.H, Chief Medical Officer, FibroGen. "We are committed to advancing the science of CTGF biology and evaluating clinical benefit in diverse diseases with unmet medical need, including IPF, locally advanced unresectable pancreatic cancer and Duchenne muscular dystrophy."

    The Phase 3 clinical development program for pamrevlumab for IPF consists of two studies, ZEPHYRUS and ZEPHYRUS-2. ZEPHYRUS is an ongoing randomized, double-blind, placebo-controlled, multi-center Phase 3 trial designed to evaluate the efficacy and safety of pamrevlumab in subjects with IPF over a 52-week period. The primary endpoint of the study is the change in forced vital capacity (FVC) from baseline. For more information about ZEPHYRUS please visit www.clinicaltrials.gov (NCT03955146).

    The design of ZEPHYRUS and ZEPHYRUS-2 is supported by safety and efficacy data from two Phase 2 studies. In a Phase 2, randomized, double-blind, placebo-controlled trial of pamrevlumab in IPF (Study 067/PRAISE), pamrevlumab demonstrated a statistically significant difference over placebo in the primary efficacy endpoint of FVC percent predicted change from baseline to Week 48 (Gorina, ERS 2017). Pamrevlumab achieved superiority over placebo in the following secondary endpoints: the proportion of subjects with disease progression (defined as a change from baseline in FVC percent predicted decline ≥10% or death), time to disease progression, change from baseline to Week 48 in quantitative lung fibrosis (QLF) score to Week 48 measured by quantitative HRCT. In addition, there was a trend towards improvement in patient-reported quality of life measurements assessed by the SGRQ (positive trends) and the UCSD-SOBQ, as well as favorable trend in all-cause mortality. 

    In a prior single-arm, open-label FGCL-3019-049 study, the treatment of patients with IPF given 15 mg/kg and 30 mg/kg IV of pamrevlumab every three weeks was associated with improvement or stability in quantified scores of whole lung fibrosis in approximately 35% of subjects at Week 48 (Raghu, 2012). Changes from baseline in these scores were significantly correlated with changes in FVC percent predicted value (Raghu, 2012).  

    About Pamrevlumab

    Pamrevlumab is a first-in-class antibody developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and for the treatment of locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD). The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) to pamrevlumab for the treatment of patients with IPF, LAPC, and DMD. Pamrevlumab has also received Fast Track designation from the U.S. Food and Drug Administration for the treatment of patients with IPF and LAPC. Across all clinical studies, pamrevlumab has consistently demonstrated a good safety and tolerability profile to date. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

    About Idiopathic Pulmonary Fibrosis (IPF)

    Idiopathic pulmonary fibrosis is a chronic lung disease characterized by a progressive and irreversible decline in lung function when lung tissue becomes damaged, stiff, and scarred. As tissue scarring progresses, transfer of oxygen into the bloodstream is increasingly impaired, leading to irreversible loss of lung function, as well as high morbidity and mortality rates. Average life expectancy is estimated to be three to five years from diagnosis with approximately two-thirds of patients dying within five years. Survival rates are comparable to those of some of the deadliest cancers.

    Patients with IPF experience debilitating symptoms, including shortness of breath and difficulty performing routine functions, such as walking and talking. Other symptoms include chronic dry, hacking cough, fatigue, weakness, discomfort in the chest, loss of appetite, and weight loss. Over the last decade, refinements in diagnosis criteria and enhancements in high-resolution computed tomography imaging technology (HRCT) have enabled more reliable diagnosis of IPF without the need for a lung biopsy.

    U.S. prevalence and incidence of IPF is estimated to be 135,000 cases (defined by ICD-9 code) and 21,000 new cases per year, respectively, based on Raghu et al. (Am J Respir Crit Care Med, 2006) and on data from the United Nations Population Division. We believe the number of patients will continue to grow due to heightened awareness and improved methods for detection and diagnosis.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contacts:

    FibroGen, Inc.

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    1.415.978.1434

    Media:

    Jennifer Harrington

    +1.610.574.9196



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  2. SAN FRANCISCO, Dec. 18, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period of the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD) by three months. The updated Prescription Drug User Fee Act (PDUFA) action date is March 20, 2021.

    The FDA is close to finalizing its review of the NDA and FibroGen is submitting additional analyses of existing roxadustat clinical data, which require an extension of the original PDUFA date.

    "FibroGen is working closely with the FDA, in collaboration with our partner, AstraZeneca, to support the final review of the new drug application for roxadustat," said Enrique…

    SAN FRANCISCO, Dec. 18, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period of the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD) by three months. The updated Prescription Drug User Fee Act (PDUFA) action date is March 20, 2021.

    The FDA is close to finalizing its review of the NDA and FibroGen is submitting additional analyses of existing roxadustat clinical data, which require an extension of the original PDUFA date.

    "FibroGen is working closely with the FDA, in collaboration with our partner, AstraZeneca, to support the final review of the new drug application for roxadustat," said Enrique Conterno, Chief Executive Officer, FibroGen. "There is significant unmet medical need for the treatment of anemia of CKD, and we are committed to bringing roxadustat to patients in the U.S. as soon as possible."

    Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by the FDA for review for the treatment of anemia of CKD. The NDA for roxadustat is based on positive results from a global Phase 3 program encompassing more than 8,000 patients.

    About Anemia of CKD

    Chronic kidney disease (CKD) is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant. CKD is estimated to occur in approximately 10-12% of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.

    Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD, affecting approximately 20% of CKD patients. Anemia of CKD is associated with an increased risk of hospitalization, cardiovascular complications, and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life. Blood transfusions are used for treating severe anemia, however, they may reduce a patient's opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.

    About Roxadustat

    Roxadustat, an oral medicine, is the first in a new class of medicines called HIF-PH inhibitors that promotes erythropoiesis, or RBC production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. Roxadustat is also in clinical development for anemia associated with MDS syndromes and for chemotherapy-induced anemia.

    Roxadustat is approved in China, Japan, and Chile for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In Europe, the Marketing Authorization Application for roxadustat for the treatment of anemia in CKD in NDD and DD patients was filed by Astellas Pharma Inc. (Astellas) and accepted by the European Medicines Agency for review in May 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, which are currently in review.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding development and commercialization of the Company's product candidates, including roxadustat regulatory events. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contacts:

    FibroGen, Inc.

    Investors:

    Michael Tung, M.D.

    Investor Relations

    +1.415.978.1434

     

    Media:

    Jennifer Harrington

    +1.610.574.9196



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  3. New data show safety and efficacy of roxadustat in treating anemia secondary to lower-risk myelodysplastic syndromes (MDS) regardless of ring sideroblast (RS) or baseline erythropoietin level

    Multiple analyses evaluate cardiovascular safety and efficacy of roxadustat in patients with anemia of chronic kidney disease (CKD) regardless of dialysis status 

    SAN FRANCISCO, Dec. 02, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) and its partner, AstraZeneca (NASDAQ:AZN), will present additional analyses of roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS) and results from multiple roxadustat phase 3 studies. Roxadustat is a first-in-class oral small molecule hypoxia-inducible factor…

    New data show safety and efficacy of roxadustat in treating anemia secondary to lower-risk myelodysplastic syndromes (MDS) regardless of ring sideroblast (RS) or baseline erythropoietin level

    Multiple analyses evaluate cardiovascular safety and efficacy of roxadustat in patients with anemia of chronic kidney disease (CKD) regardless of dialysis status 

    SAN FRANCISCO, Dec. 02, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) and its partner, AstraZeneca (NASDAQ:AZN), will present additional analyses of roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (MDS) and results from multiple roxadustat phase 3 studies. Roxadustat is a first-in-class oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in development for the treatment of patients with anemia of CKD and anemia secondary to lower-risk MDS. FibroGen and its partner will present eight abstracts at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, taking place virtually December 5-8, 2020.

    "We are pleased to share additional 52-week data from the open-label portion of our Phase 3 anemia of MDS trial with the medical community at ASH," said Enrique Conterno, Chief Executive Officer, FibroGen. "In addition, we are presenting Phase 3 cardiovascular safety and efficacy results of roxadustat, which highlight its potential in a broad range of CKD patients."

    MDS is a group of blood disorders characterized by poorly formed or dysfunctional blood cells, resulting in chronic anemia.1 Exploratory analyses to be presented at ASH show the efficacy of roxadustat in transfusion-dependent lower-risk MDS patients regardless of ring sideroblast and baseline erythropoietin status - characteristics used to predict response to treatment.2 Patients with ring sideroblasts (RS+), without ring sideroblasts (RS-), baseline erythropoietin (BL EPO) ≤ 200 mIU/ml, and BL EPO > 200 mIU/ml achieved the primary endpoint of transfusion independence for ≥ 8 weeks during the first 28 treatment weeks (23% of MDS-RS+, 55% of MDS-RS-, 39% of BL EPO ≤ 200 mIU/ml, and 33% of BL EPO > 200 mIU/ml patients). Detailed results will be presented at the meeting.

    Enrollment in the double-blind placebo-controlled portion of the Phase 3 roxadustat study of patients with anemia secondary to lower-risk MDS is ongoing (NCT03263091).

    Roxadustat presentations during the 62nd ASH Annual Meeting and Exposition:

    PresenterPresentation titlePresentation details
    David Henry, MDOral Roxadustat Demonstrates Efficacy in Anemia Secondary to Lower-Risk Myelodysplastic Syndrome Irrespective of Ring Sideroblasts and Baseline Erythropoietin LevelsePoster #1277

    Session 637: Myelodysplastic Syndromes—Clinical Studies (Poster I)

    Sat., Dec. 5: 7:00 AM–3:30 PM PT
    Steven Fishbane, MDRoxadustat Lowers Risk of RBC Transfusion in Patients with Anemia of CKD



    ePoster #748

    Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)

    Sat., Dec. 5: 7:00 AM–3:30 PM PT
    Steven Fishbane, MDPooled Efficacy and Cardiovascular Safety Results of Roxadustat Compared with Epoetin Alfa in the Treatment of Anemia in Chronic Kidney Disease Patients on DialysisePoster #749

    Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)

    Sat., Dec. 5: 7:00 AM–3:30 PM PT
    Carol Pollock, MDRoxadustat Increases Hemoglobin in Anemic Non-Dialysis-Dependent (NDD) Chronic Kidney Disease (CKD) Patients Independent of InflammationePoster #757

    Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)

    Sat., Dec. 5: 7:00 AM–3:30 PM PT
    Roberto Pecoits-Filho, MDRoxadustat Treatment Results in Consistent Improvements in Hemoglobin (Hb) Versus Placebo: An Analysis of 3 Multinational RCTs in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)ePoster #758

    Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)

    Sat., Dec. 5: 7:00 AM–3:30 PM PT
    Anjay Rastogi, MDRoxadustat Treatment Corrects Anemia to Hemoglobin (Hb) Values ≥10 g/dL in the Majority of Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)ePoster #761

    Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster I)

    Sat., Dec. 5: 7:00 AM–3:30 PM PT
    Steven Fishbane, MDHemoglobin (Hb) Correction with Roxadustat is Associated with Improved Iron Homeostasis in Patients with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)ePoster #766

    Session 102: Regulation of Iron Metabolism (Poster I)

    Sat., Dec. 5: 7:00 AM–3:30 PM PT
    Robert Provenzano, MDPooled Efficacy and Cardiovascular Analysis of Roxadustat Compared with Placebo in Anemia Correction in Chronic Kidney Disease Patients Not on DialysisePoster #1671

    Session 101: Red Cells and Erythropoiesis, Structure and Function, Metabolism, and Survival, Excluding Iron (Poster II)

    Sun., Dec. 6: 7:00 AM–3:30 PM PT

    About Anemia of CKD

    Chronic kidney disease (CKD) is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant. CKD is estimated to occur in approximately 10-12% of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.

    Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD, affecting approximately 20% of CKD patients. Anemia of CKD is associated with an increased risk of hospitalization, cardiovascular complications, and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life. Blood transfusions are used for treating severe anemia, however, they may reduce a patient's opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.

    About MDS

    MDS develops because the bone marrow cells do not develop into mature blood cells. Instead, these blood cells stay within the bone marrow in an immature state. There are many subtypes of MDS. Some cases are mild, while others are more severe, and carry a high risk of becoming acute myelogenous leukemia (AML). It is estimated that more than 10,000 patients are diagnosed with MDS each year in the U.S.,3 and overall prevalence is estimated to be between 60,000 – 170,000 in the country.4

    About Roxadustat

    Roxadustat is a first-in-class orally administered inhibitor of HIF-PH, which increases hemoglobin levels through a mechanism of action that is different from that of traditional erythropoiesis-stimulating agents. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. Roxadustat promotes red blood cell production through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production.

    Roxadustat is approved and launched for the treatment of anemia of CKD in Japan and China in adult patients on dialysis (DD) and not on dialysis (NDD). A New Drug Application for the treatment of anemia of CKD in patients both DD and NDD is under review by the U.S. Food and Drug Administration with a decision expected in December 2020. The marketing authorization application for roxadustat for the treatment of anemia of CKD in patients both DD and NDD was accepted by the European Medicines Agency for review on May 21, 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, which are currently in review.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contacts:

    FibroGen, Inc.

    Investors:

    Michael Tung, M.D.

    Investor Relations

    +1.415.978.1434

    Media:

    Jennifer Harrington

    +1.610.574.9196


    1 American Cancer Society. What Are Myelodysplastic Syndromes? Available at https://www.cancer.org/cancer/myelodysplastic-syndrome/about/what-is-mds.html. Accessed November 2020.

    2 Abu-Zeinah G, DeSancho MT. Understanding Sideroblastic Anemia: An Overview of Genetics, Epidemiology, Pathophysiology and Current Therapeutic Options. J Blood Med. 2020;11:305-318. Published 2020 Sep 25. doi:10.2147/JBM.S232644

    3 Ma X, Does M, Raza A, Mayne ST. Myelodysplastic syndromes: incidence and survival in the United States. Cancer. 2007;109(8):1536.

    4 Cogle CR. Incidence and Burden of the Myelodysplastic Syndromes. Curr Hematol Malig Rep. 2015;10(3):272-281.



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  4. SAN FRANCISCO, Dec. 01, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced the retirement of K. Peony Yu, M.D., Chief Medical Officer, and appointment of Mark Eisner, M.D., M.P.H. in that role. Dr. Yu will continue as Chief Medical Officer through December 20, 2020, the roxadustat PDUFA date, and will remain with FibroGen through March 15, 2021 serving as Executive Advisor to the CEO to support the transition.

    Dr. Yu joined FibroGen in 2008 and has provided key leadership for global clinical development across the company, leading the development of roxadustat in multiple indications and advancement of the overall portfolio.

    "On behalf of the board, shareholders, and our employees, I want to thank Peony for her tremendous…

    SAN FRANCISCO, Dec. 01, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced the retirement of K. Peony Yu, M.D., Chief Medical Officer, and appointment of Mark Eisner, M.D., M.P.H. in that role. Dr. Yu will continue as Chief Medical Officer through December 20, 2020, the roxadustat PDUFA date, and will remain with FibroGen through March 15, 2021 serving as Executive Advisor to the CEO to support the transition.

    Dr. Yu joined FibroGen in 2008 and has provided key leadership for global clinical development across the company, leading the development of roxadustat in multiple indications and advancement of the overall portfolio.

    "On behalf of the board, shareholders, and our employees, I want to thank Peony for her tremendous contributions as Chief Medical Officer of FibroGen," said Enrique Conterno, Chief Executive Officer, FibroGen. "With her considerable expertise and leadership, roxadustat was approved in China and Japan for the treatment of CKD anemia with pending regulatory decisions in the US, EU, and additional countries, to potentially serve millions of patients worldwide."

    "It has been my privilege to work with many talented colleagues at FibroGen to make a difference in the lives of many," said Dr. Yu. "I look forward to our upcoming roxadustat U.S. PDUFA date, and expect FibroGen will continue to advance important new medicines."

    Mark Eisner, M.D., M.P.H. has joined FibroGen as of today, and will become Chief Medical Officer effective December 21, 2020, overseeing all global clinical development and regulatory affairs for FibroGen. Dr. Eisner has nearly 30 years of academic, biopharmaceutical, and drug development experience, from early clinical phase through post-commercialization.

    "Mark's extensive leadership, clinical development, and regulatory expertise come at a critical time for the company as we accelerate our development and look ahead to multiple significant clinical milestones. The depth and breadth of his therapeutic development experience is an ideal fit, and we are thrilled to welcome him to the FibroGen team," said Enrique Conterno, Chief Executive Officer, FibroGen. "We look forward to Mark's contributions as a proven business leader, clinician, and researcher in our continued evolution toward becoming a commercial-stage biopharmaceutical company with a maturing clinical pipeline."

    "I am excited to lead the clinical development organization during this important time at FibroGen, when the company is rapidly advancing its robust late-stage pipeline," said Dr. Eisner. "I look forward to progressing the current clinical studies to bring valuable medicines to patients."

    Dr. Eisner, who brings more than 10 years of experience in clinical drug development and 20 years as a practicing physician, has held leadership positions in academic medicine, clinical research, and pharmaceutical development. In 2010, he joined Genentech, a member of the Roche Group, and was most recently Senior Vice President and Global Head of Product Development Immunology, Infectious Disease, and Ophthalmology where he led clinical development for areas including respiratory medicine, rheumatology, nephrology, inflammatory bowel disease, virology, and retinal disease.

    Prior to Genentech, Mark was Professor of Medicine and Anesthesia at the University of California San Francisco where he was an internationally recognized expert on clinical research in acute and chronic lung disease. He served as a steering committee member and ultimately UCSF Principal Investigator for the National Heart, Lung, and Blood Institute ARDS Clinical Trials Network which conducted several clinical landmark trials. Mark also built a world-class NIH-funded clinical research program focusing on the epidemiology and long-term health outcomes of obstructive lung disease. He was also an investigator in the UCSF Cardiovascular Research Institute. Mark published ~200 peer-reviewed articles, served on multiple NIH study sections, and was a member of the American Thoracic Society Board of Directors.

    Mark graduated from Stanford University with an A.B. degree in Human Biology and then received his M.D. degree from the University of Pennsylvania School of Medicine. He completed residency training in internal medicine, served as Chief Medical Resident, and pursued advanced fellowship training in pulmonary and critical care medicine at the University of California, San Francisco. He also received a M.P.H. degree from the University of California, Berkeley School of Public Health.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, our clinical programs and regulatory events and those of our partners, and the commercial prospects of roxadustat. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contacts:

    FibroGen, Inc.

    Investors:

    Michael Tung, M.D.

    Investor Relations

    +1.415.978.1434

    Media:

    Jennifer Harrington

    +1.610.574.9196



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  5. SAN FRANCISCO and TOKYO, Nov. 27, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN, CEO: Enrique Conterno, "FibroGen"))) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO® (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on dialysis. This marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched for use in adult patients with anemia of CKD on dialysis last year.

    "We are delighted roxadustat is now approved in Japan for adults with anemia of CKD not on dialysis, as it allows…

    SAN FRANCISCO and TOKYO, Nov. 27, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN, CEO: Enrique Conterno, "FibroGen"))) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO® (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on dialysis. This marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched for use in adult patients with anemia of CKD on dialysis last year.

    "We are delighted roxadustat is now approved in Japan for adults with anemia of CKD not on dialysis, as it allows even more patients to access this important new treatment option," said Bernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas. "With its novel mechanism of action and oral administration, we hope roxadustat will alleviate some of the burden associated with anemia of CKD prior to the initiation of dialysis and deliver meaningful improvements in the lives of these patients."

    This approval is based on results obtained from three clinical studies in more than 500 Japanese patients with anemia of CKD not on dialysis. The first, an open-label Phase 3 conversion study versus active comparator, darbepoetin alfa, met the primary efficacy endpoint of non-inferiority and continued to demonstrate maintenance of hemoglobin (Hb) levels over time.1 Roxadustat was generally well tolerated, and the safety profile was comparable with that of darbepoetin alfa.1 The other two studies (one Phase 3 and one Phase 2) support the safety and efficacy of roxadustat in erythropoiesis-stimulating agent (ESA)-untreated patients.2,3

    "Today's approval is another milestone achievement for both FibroGen and Astellas," said K. Peony Yu, M.D., Chief Medical Officer, FibroGen. "By bringing roxadustat to adult patients living with anemia of CKD, both on dialysis and not on dialysis, we are continuing our efforts to meet the significant unmet medical need of patients in this community."

    The approval of the supplementary New Drug Application (sNDA) for roxadustat in Japan for the treatment of anemia of CKD in adult patients not on dialysis triggers a milestone payment of $15 million by Astellas to FibroGen.

    As a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), roxadustat increases Hb levels through a mechanism of action that is different from that of traditional ESAs. As a HIF-PH inhibitor, roxadustat activates the body's natural protective response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anemia.

    Product Information

    PRODUCT NAMEEVRENZO® Tablets 20 mg

    EVRENZO® Tablets 50 mg

    EVRENZO® Tablets 100 mg
    GENERAL NAMERoxadustat
    INDICATIONSRenal anemia
    DOSAGE AND ADMINISTRATIONPatients not on erythropoiesis-stimulating agent treatment.

    For adults, the usual dosage is 50 mg, the starting dose, as roxadustat orally administered three times weekly. The dosage thereafter should be adjusted according to the patient's condition; however, the maximum dose should not exceed 3.0 mg/kg.



    Patients switching from erythropoiesis-stimulating agents.

    For adults, the usual dosage is 70 or 100 mg, the starting dose, as roxadustat orally administered three times weekly. The dosage thereafter should be adjusted according to the patient's condition; however, the maximum dose should not exceed 3.0 mg/kg.
    APPROVAL DATESRenal anemia in patients on dialysis: September 20, 2019

    Renal anemia in patients not on dialysis: November 27, 2020

    About Clinical Trials

    For more information about the clinical trials associated with this approval (1517-CL-0310, 1517-CL-0314, 1517-CL-0303), please visit www.clinicaltrials.gov.

    About CKD and Anemia

    CKD is characterized by a progressive loss of kidney function caused by damage to the kidneys resulting from conditions such as hypertension, diabetes or immune-regulated inflammatory conditions.4,5 Worldwide, 1 in 10 people are living with CKD.6 In Japan specifically, the prevalence of CKD has increased significantly over time.7 Although CKD can occur at any age, it becomes more common in aging populations and the prevalence is increasing.8 In addition, CKD is predicted to become the fifth most common cause of premature death by 2040 globally.9 It is a critical worldwide healthcare issue that represents a large and growing unmet medical need.

    Anemia is a common complication of CKD,10 resulting from the failing kidneys' ability to produce erythropoietin, reduced oxygen sensing, and increased hepcidin and iron deficiency resulting from chronic inflammation. Anemia affects approximately one-third of Japanese patients with Stage 3–5 CKD.11 It is associated with significant morbidity and mortality in dialysis and non-dialysis populations, increasing in both prevalence and severity as kidney disease worsens.12 Anemia of CKD increases the risk of adverse cardiovascular events, worsens renal outcomes and can negatively impact patients' quality of life.13-15

    About Roxadustat

    Roxadustat is a first-in-class orally administered inhibitor of HIF-PH, which increases hemoglobin levels through a mechanism of action that is different from that of traditional erythropoiesis-stimulating agents. As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. Roxadustat promotes red blood cell production through increased endogenous production of erythropoietin; improved iron absorption, transport, and mobilization; and downregulation of hepcidin, which helps to overcome the negative impact of inflammation on hemoglobin synthesis and red blood cell production.

    Roxadustat is approved and launched for the treatment of anemia of CKD in Japan and China in adult patients on dialysis (DD) and not on dialysis (NDD). A New Drug Application for the treatment of anemia of CKD in patients both DD and NDD is under review by the U.S. Food and Drug Administration with a decision expected in December 2020. The marketing authorisation application for roxadustat for the treatment of anemia of CKD in patients both DD and NDD was accepted by the European Medicines Agency for review on May 21, 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, which are currently in review.

    Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China and other markets in the Americas and in Australia/New Zealand as well as Southeast Asia.

    About Astellas

    Astellas Pharma Inc., is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

    About FibroGen

    FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing and commercializing a pipeline of first-in-class therapeutics. The company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). For more information, please visit www.fibrogen.com.

    Astellas Cautionary Notes

    In this press release, statements made with respect to current plans, estimates, strategies and beliefs, and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets and (vi) infringements of Astellas' intellectual property rights by third parties.

    Information about pharmaceutical products (including products currently in development) that is included in this press release is not intended to constitute an advertisement or medical advice.

    FibroGen Forward-Looking Statements

    This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "will", "should," "on track," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.

    Contacts for inquiries or additional information:

    Astellas Portfolio Communications

    Anna Otten

    TEL: +1 (224) 205-6651 | Email:

    Astellas Pharma Inc.

    Corporate Advocacy & Relations

    TEL: +81-3-3244-3201 FAX: +81-3-5201-7473

    FibroGen, Inc.

    Investors:

    Michael Tung, M.D.

    Corporate Strategy / Investor Relations

    TEL: 1.415.978.1433 | Email:

    Media Inquiries:

    Jennifer Harrington

    +1.610.574.9196

    REFERENCES


    1 Akizawa T, Iwasaki M, Otsuka T, et al. A Phase 3, Multicenter, Randomized, Open-label, Active Comparator Conversion Study of Roxadustat in Non–Dialysis-Dependent (NDD) Patients with Anemia in Chronic Kidney Disease (CKD). E-poster presented at the American Society of Nephrology Kidney Week Congress; October 22, 2020; US.

    2 Akizawa T, Yamaguchi Y, Otsuka T, Reusch M. A Phase 3, Multicenter, Randomized, Two-Arm, Open-Label Study of Intermittent Oral Dosing of Roxadustat for the Treatment of Anemia in Japanese Erythropoiesis-Stimulating Agent-Naïve Chronic Kidney Disease Patients Not on Dialysis. Nephron 2020;144:372–382.

    3 Akizawa T, Iwasaki M, Otsuka T, et al. Roxadustat Treatment of Chronic Kidney Disease-Associated Anemia in Japanese Patients Not on Dialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial. Adv Ther 2019;36:1438–1454.

    4 Ojo A. Addressing the Global Burden of Chronic Kidney Disease Through Clinical and Translational Research. Trans Am Clin Climatol Assoc 2014;125:229–246.

    5 Tecklenborg J, Clayton D, Siebert S, and Coley SM. The role of the immune system in kidney disease. Clin Exp Immunol 2018; 192: 142–150.

    6 International Society of Nephrology. Chronic Kidney Disease. Global Kidney Health Atlas 2017 [online]. Available from: www.theisn.org/global-atlas [Last accessed: October 2020].

    7 Nagata M, Ninomiya T, Doi Y, et al. Trends in the prevalence of chronic kidney disease and its risk factors in a general Japanese population: The Hisayama Study. Nephrol Dial Transplant 2010;25:2557–2564.

    8 Tonelli M, Riella M. Chronic kidney disease and the aging population. Indian J Nephrol 2014;24:71–74.

    9 Institute for Health Metrics and Evaluation (IHME). Findings from the Global Burden of Disease Study 2017 [online] 2018. Available from: http://www.healthdata.org/sites/default/files/files/policy_report/2019/GBD_2017_Booklet.pdf [Last accessed: October 2020].

    10 McClellan W, Aronoff SL, Kline Bolton W, et al. The prevalence of anemia in patients with chronic kidney disease. Curr Med Res Opin 2004;20:1501–1510.

    11 Akizawa T, Okumura H, Alexandre AF, et al. Burden of Anemia in Chronic Kidney Disease Patients in Japan: A Literature Review. Ther Apher Dial 2018;22:444–456.

    12 Stauffer ME, Fan T. Prevalence of Anemia in Chronic Kidney Disease in the United States. PLoS One 2014;9:e84943.

    13 Mohanram A, Zhang Z, Shahinfar S, et al. Anemia and end-stage renal disease in patients with type 2 diabetes and nephropathy. Kidney Int 2004;66:1131–1138.

    14 Weiner DE, Tighiouart H, Stark PC, et al. Kidney disease as a risk factor for recurrent cardiovascular disease and mortality. Am J Kidney Dis 2004;44:198–206.

    15 Eriksson D, Goldsmith D, Teitsson S, et al. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrol 2016;17:97.

     



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