FDA Approves Doptelet For Thrombocytopenia In Adults With Chronic Liver Disease

(RTTNews) - The U.S. Food and Drug Administration Monday approved Dova Pharma's New Drug Application for Doptelet, or Avatrombopag, tablets to treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease.

This is the first drug approved by the FDA for this use. The drug application for Avatrombopag was under Priority Review by the FDA.

"Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding," said Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions."

The orally administered Avatrombopag is proposed for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure.

Thrombocytopenia is a condition characterized by abnormally low levels of platelets in the blood, and which is a common complication in patients with chronic liver disease. An estimated 1.1 million chronic liver disease patients in the United States are said to be affected by thrombocytopenia.

Platelets are colorless cells produced in the bone marrow that help form blood clots in the vascular system and prevent bleeding.

The primary intellectual property related to Avatrombopag is licensed to Dova from Astellas on an exclusive, worldwide basis under the terms of a license agreement that was acquired from Eisai.