Amgen Wins FDA Approval For Blood Platelet Drug
Amgen has announced that the FDA has approved Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized and non-splenectomized adults with chronic immune thrombocytopenic purpura.
According to the company, Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.
The FDA approval of Nplate was based on efficacy and safety results from two pivotal Phase III studies of adult patients with chronic immune thrombocytopenic purpura (ITP), including both splenectomized and non-splenectomized patients.
Amgen has also announced that it will launch the Nplate Nexus program, a multi-faceted program designed to provide comprehensive access, support and education for chronic ITP patients, their caregivers and healthcare providers. The Nplate Nexus program is part of the risk evaluation and mitigation strategy developed by Amgen in partnership with the FDA to assure safe use of Nplate while minimizing risk.
The program will facilitate appropriate use of Nplate, provide patient support through education and resources and help with ongoing follow up through safety data collection.
Roger Perlmutter, executive vice president of R&D at Amgen, said: "The FDA approval of Nplate is the result of more than 15 years of research and represents an important biotechnology milestone as it is the first FDA-approved peptibody protein, an innovative platform for delivering targeted therapies." www.datamonitor.com
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SOURCE: Amgen