The US Food and Drug Administration (FDA) has approved Doptelet (avatrombopag) tablets — a new drug for the treatment of patients with chronic liver disease who have low blood platelets and are undergoing a medical or dental procedure.
“Patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding,” said Dr 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 safety and efficacy of Doptelet was investigated in two trials (ADAPT-1 and ADAPT-2), which included 435 patients with chronic liver disease and severe thrombocytopenia who were scheduled to undergo a procedure that would typically involve platelet transfusion. In these trials, two dose levels of Doptelet, administered orally over five days, were assessed in comparison with a placebo.
It was found that at both dose levels more patients experienced an increased platelet count compared with those administered with a placebo and did not require platelet transfusion or any rescue therapy on the day of the procedure and up to seven days following the procedure.
Approval of this treatment was granted to AkaRx.