Markets

Amgen: FDA Approves Earlier Use Of Nplate To Treat Immune Thrombocytopenia

(RTTNews) - 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."

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story

AMGN