FDA Approves Expanded Use of Doptelet to Treat Thrombocytopenia

The U.S. Food and Drug Administration (FDA) has approved an expanded indication for Dova Pharmaceuticals’ Doptelet (avatrombopag) to treat adults with chronic immune thrombocytopenia who had an insufficient response to a previous treatment. Previously, Doptelet was approved to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure. The company launched Doptelet commercially for immune thrombocytopenia purpura (ITP) in mid-July. According to a company statement, Doptelet will be priced similarly to other thrombopoietin receptor agonists used to treat ITP, and the company will continue to offer patient assistance and copay programs.

“ITP patients should work with their clinician to choose a therapy that supports their lifestyle and aims to achieve the best possible result to treat their ITP,” said Caroline Kruse, president and CEO of the Platelet Disorder Support Association. “That’s why having additional treatment options are so important. We are thrilled to have a new oral TPO-RA available for adult patients with ITP. Every new treatment provides more choices and new hope to our community.”