The U.S. Food and Drug Administration approved Dova Pharmaceuticals Inc.'s Doptelet to treat low blood platelet count in adults with chronic liver disease who are scheduled to have a medical or dental procedure.
Doptelet, or avatrombopag, is the first FDA-approved, orally administered treatment for thrombocytopenia, a condition characterized by an abnormally low platelet count, in adult patients with chronic liver disease. Patients with this condition receive platelet transfusions immediately before their scheduled procedure to increase the platelet count.
The approval was granted based on the safety and efficacy results of two trials, Adapt-1 and Adapt-2, conducted among 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion.
In the trials, patients who received the drug experienced an increase in their platelet counts and did not need platelet transfusion or any rescue therapy on the day of the procedure, as well as up to seven days after the procedure compared to placebo.
The drug was previously granted priority review by the FDA.
Dova Pharmaceuticals said the drug will be commercially launched in June.
