Dova Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) has completed their Priority Review and approved DOPTELET (avatrombopag) for the treatment of thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure; this represents the first thrombopoietin (TPO) receptor agonist approved in the United States for this indication. The DOPTELET label reflects the consistent safety and efficacy data from two global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials that met all primary and secondary endpoints, and supported the approval of DOPTELET.
“We are delighted FDA has approved DOPTELET, which represents a significant milestone for Dova, physicians, and most importantly, patients,” said Alex C. Sapir, President and Chief Executive Officer. “DOPTELET is the first orally administered treatment option for patients with CLD, allowing 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. Given our extensive preparations to date, we are positioned to launch DOPTELET in June with our full complement of sales, marketing, and reimbursement support resources.”
Norah Terrault, M.D, M.P.H., Professor of Medicine at the University of California San Francisco, Division of Gastroenterology, and Principal Investigator for the Phase 3 pivotal avatrombopag trials said, “Given the need for patients with CLD to routinely undergo multiple, invasive procedures, the availability of an oral agent that can lead to a measured increase in platelets, to minimize the need for platelet transfusions and risk of bleeding, will facilitate the clinical management of these patients.”