FDA approves Doptelet for chronic immune thrombocytopenia

The FDA expanded the approval of avatrombopag to include treatment of adults with chronic immune thrombocytopenia who had insufficient response to previous treatment.

Avatrombopag (Doptelet, Dova Pharmaceuticals) — an oral thrombopoietin receptor agonist administered with food — already had been approved for treatment of thrombocytopenia among adults with chronic liver disease who are scheduled to undergo a procedure.

The FDA based the chronic immune thrombocytopenia (ITP) indication in part on results of a phase 3 study that showed avatrombopag administration resulted in a platelet count of at least 50,000 per µL at day 8 of therapy for most patients with chronic immune thrombocytopenia. The agent appeared superior to placebo for maintaining platelet counts in the target range during the 6-month target period.

- From Healio.com

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