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.
This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of March 12, 2008 and expressly disclaims any duty to update information contained in this news release.
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.
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 (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia - December 14, 2018
- 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
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