Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) – The Cardiovascular and Renal Drugs Advisory Committee will discuss new drug application (NDA) proposed trade name NORTHERA (droxidopa capsules) on February 23, 2012, for the treatment of symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson’s Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency, and Non-Diabetic Autonomic Neuropathy
Astex Pharmaceuticals, Inc (NASDAQ:ASTX) – The Oncologic Drugs Advisory Committee will review the supplemental new drug application (NDA) for DACOGEN (decitabine) for injection on February 9, 2012. The proposed indication (use) for this product is for the treatment of acute myelogenous leukemia (AML) in adults 65 years of age or older who are not considered candidates for induction chemotherapy, which is the standard first phase of treatment for AML.
During the afternoon session, the committee will discuss the NDA proposed of trade name PIXUVRI (pixantrone dimaleate) injection, application submitted by Cell Therapeutics, Inc. (CTIC). The proposed indication (use) for this product is as a single agent treatment for patients with relapsed or refractory (difficult to treat), aggressive Non-Hodgkin’s Lymphoma who received two or more prior lines of therapy.
Gentium S.p.A. (Nasdaq:GENT) provided an update on its European Marketing Authorization Application for Defibrotide (MAA) to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem-cell transplantation therapy. Last month it noted an intention to submit a response to the Day 120 List of Questions (LoQs) from CHMP (Committee for Medical Products for Human Use) by the end of this year. However, the company now expects to submit it during 1Q 2012. The EMA is expected to issue an opinion 30 days following the response or may list any outstanding issues that need to be resolved.