Trials & Filings

Amgen’s Nplate Approved for ITP

Phase III study shows overall platelet response was increased with the Nplate group (71 percent) compared with placebo

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By: Kristin Brooks

Managing Editor, Contract Pharma

Amgen received approval from the FDA for the supplemental Biologics License Application (sBLA) for Nplate (romiplostim) for the treatment of pediatric patients one year of age and older with immune thrombocytopenia (ITP) for at least six months who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.  The approval was based on two placebo-controlled studies evaluating the safety and efficacy of Nplate in pediatric patients. In the Phase III study, rates of ove...

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