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