NplateTreatment for Idiopathic (Immune) Thrombocytopenic Purpura
Update: Nplate Now FDA Approved - August 22, 2008
Outcome of Romiplostim FDA Meeting
Amgen Statement on Successful Outcome of Romiplostim Panel Meeting
THOUSAND OAKS, Calif.--(BUSINESS WIRE)--March 12, 2008--Amgen Inc. 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).
"We 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.
"We 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."
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science'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 people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
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CONTACT: Amgen, Thousand Oaks
Christine Regan: 617-359-1324 (media)
John Shutter: 805-447-1060 (investors)
SOURCE: Amgen Inc.
Posted: March 2008
- FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP - August 22, 2008
- Amgen's FDA Nplate Approval Statement Retracted - July 15, 2008
- FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP - July 14, 2008
- Amgen to Discuss Romiplostim Application at FDA ODAC Meeting - March 12, 2008