FDA approves Doptelet for thrombocytopenia in adults with chronic liver disease
The FDA approved avatrombopag to treat low blood platelet count among adults with chronic liver disease who are scheduled to undergo a medical or dental procedure.
Avatrombopag (Doptelet, Dova/AkaRx) is the first drug to receive FDA approval for this indication.
The FDA based this approval on results from two trials — ADAPT-1 and ADAPT-2 — that included 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically require platelet transfusion. Compared with placebo, a higher rate of patients administered avatrombopag demonstrated increased platelet counts and did not require transfusion or any rescue therapy on the day of their procedure and up to 7 days following the procedure.
“Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding,” Richard Pazdur, MD, 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, said in a press release. “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 most common side effects among patients receiving avatrombopag included fever, abdominal pain, nausea, headache, fatigue and edema. People with chronic liver disease and people with certain blood clotting conditions may have an increased risk for developing blood clots when taking avatrombopag.