FDA Panel Backs Amgen Drug for Blood Disorder
THOUSAND OAKS, Calif. -- Amgen today issued the following statement on the outcome of the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting on romiplostim, a investigational thrombopoietin mimetic peptibody, for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).
â€œWe are pleased that the panel today recognized the importance of this therapeutic advance and unanimously voted to recommend approval of the romiplostim application. We believe that this product has the potential to be an important new treatment option for the orphan population of adult patients suffering from chronic ITP. Patients with chronic ITP, a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia) face the risk of bleeding events due to low platelet counts.
â€œWe look forward to continued productive discussions with the FDA. We strongly believe the data contained in our registrational clinical studies paired with the proposed comprehensive risk management program support approval by the FDA in the second quarter of this year.â€
Amgen discovers, develops 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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