THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) said the FDA has approved the Supplemental Biologics License Application (sBLA) for Nplate to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia. The updated indication expands treatment with Nplate to newly diagnosed and persistent adult immune thrombocytopenia patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
David Reese, executive vice president of Research and Development at Amgen, stated: 'This approval will provide patients the opportunity to receive Nplate earlier in the course of their disease, potentially reducing their need for prolonged steroid use.'
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