FDA Approves Amgen’s Nplate

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has approved Amgen‘s Nplate, the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). 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 Pha...

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