FDA Decision on Amgen Clotting Drug Delayed
THOUSAND OAKS, Calif. -- Amgen Inc. today issued the following statement on the Prescription Drug User Fee Act (PDUFA) date for romiplostim.
â€œAmgen has received notification from the U.S. Food and Drug Administration (FDA) that the action date for FDAâ€™s priority review of Biologics License Application (BLA) for romiplostim for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenic purpura (ITP) has been extended to July 23, 2008. The original action date for the BLA was April 23, 2008.
â€œFollowing the March 12 Oncologic Drugs Advisory Committee (ODAC) meeting, Amgen provided to the FDA a robust risk management program designed to optimize appropriate use of romiplostim in ITP patients. The FDA considers this additional information to be a major amendment to the romiplostim BLA, which triggers a three-month review extension according to the current PDUFA rules.
â€œThe ODAC unanimously voted to recommend approval of romiplostim for this indication. We look forward to continued productive discussions with the FDA. Amgen believes the data contained in our registrational clinical studies paired with our proposed comprehensive risk management program, together support approval by the FDA, providing ITP patients with a potential new treatment option.â€
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new scienceâ€™s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve peopleâ€™s lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
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