Amgen (NASDAQ:AMGN) today announced the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Nplate® (romiplostim) to include the treatment of adult patients with immune thrombocytopenia (ITP) who have had ITP for 12 months or less and an insufficient response to corticosteroids, immunoglobulins or splenectomy.
| THOUSAND OAKS, Calif., /PRNewswire/ --Amgen (NASDAQ:AMGN) today announced the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Nplate® (romiplostim) to include the treatment of adult patients with immune thrombocytopenia (ITP) who have had ITP for 12 months or less and an insufficient response to corticosteroids, immunoglobulins or splenectomy. “Patients living with ITP need more flexibility in their treatment options, and we believe Nplate has the potential to play a role earlier in the paradigm,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We are proud that Nplate has helped thousands of patients with chronic ITP and look forward to working with the FDA on this expanded label application.” The submission is supported by nine studies evaluating the safety and efficacy of Nplate in adults with ITP, including two long-term open-label extension studies. Expansion of the indication for Nplate to include adult patients with ITP for 12 months or less is supported by data from 311 patients who were diagnosed with ITP within 12 months prior to study enrollment. ITP is a rare, serious autoimmune disease characterized by low platelet counts in the blood (a condition known as thrombocytopenia) and impaired platelet production.1 In the U.S., the estimated incidence of ITP is 3.3 per 100,000 adults annually.1 About Nplate® (romiplostim) Nplate is a thrombopoietin (TPO) receptor agonist that mimics the body’s natural TPO and is designed to increase platelet counts in patients with chronic immune thrombocytopenia (ITP).2 In the U.S. and European Union (EU), Nplate is approved for the treatment of chronic ITP in adults who have had an insufficient response to other medicines or had surgery to remove the spleen. In the U.S. and EU, Nplate is also approved for the treatment of ITP in children age one year and older who have had the disease for at least six months and who have had an insufficient response to other medicines or had surgery to remove the spleen. Nplate is also approved in 67 countries, including Canada and Australia. For more information about Nplate, please visit www.Nplate.com. Important U.S. Nplate® Safety Information Risk of Progression of Myelodysplastic Syndromes to Acute Myelogenous Leukemia
Thrombotic/Thromboembolic Complications
Loss of Response to Nplate®
Adverse Reactions Adult ITP
Pediatric ITP
Nplate® administration may increase the risk for development or progression of reticulin fiber formation within the bone marrow. This formation may improve upon discontinuation of Nplate®. In a clinical trial, one patient with ITP and hemolytic anemia developed marrow fibrosis with collagen during Nplate® therapy. Women who become pregnant during Nplate® treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800‑77‑AMGEN (1-800‑772‑6436) to enroll. Please see full U.S. Prescribing Information and Medication Guide at www.Nplate.com. About Amgen Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. Forward-Looking Statements This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. 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 reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. 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Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. 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 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. CONTACT: References:
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Company Codes: NASDAQ-NMS:AMGN |
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