The FDA on Monday approved Dova Pharmaceuticals' Doptelet (avatrombopag) as the first treatment for adults with thrombocytopaenia due to chronic liver disease who are slated to undergo a medical or dental procedure. Richard Pazdur, acting director of the Office of Hematology and Oncology Products in the agency's Center for Drug Evaluation and Research, commented "patients with chronic liver disease who have low platelet counts and require a procedure are at increased risk of bleeding," adding "this drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions."
According to the FDA, the approval was supported by safety and efficacy data from the ADAPT-1 and ADAPT-2 trials involving a total of 435 patients with chronic liver disease and severe thrombocytopaenia who were scheduled for a medical procedure that would typically require platelet transfusion. Results unveiled last year showed that Doptelet met the primary and secondary efficacy endpoints of both studies, with a greater percentage of treated patients exhibiting increased platelet counts and no requirement for platelet transfusion or rescue therapy the day of the procedure and through seven days after the procedure versus placebo.
Dova CEO Alex Sapir noted that Doptelet allows "the majority of patients to avoid a platelet transfusion prior to a procedure by increasing platelet counts to the target level of greater or equal to 50,000 per microliter." Sapir indicated that the company is plans to launch the product next month.
Dova submitted Doptelet, a second-generation oral thrombopoietin receptor agonist, for FDA approval for this indication last September, with the agency awarding the filing priority review in November.
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