Dova Pharmaceuticals Announces European Union Marketing Authorization for DOPTELET®

Dova Pharmaceuticals (NASDAQ:DOVA) has announced that the European Commission (EC) has authorized DOPTELET for treating severe thombocytopenia in adult patients with chronic liver disease.

As quoted in the press release:

“Receiving the European marketing authorization for DOPTELET marks another significant milestone for Dova and our growing leadership in the treatment of thrombocytopenia,” said Dr. David Zaccardelli, president and chief executive officer of Dova.  “As an oral thrombopoietin receptor agonist that can raise platelet levels in CLD patients with thrombocytopenia ahead of an invasive procedure, DOPTELET offers a safe and effective alternative to platelet transfusions. Conversations with potential commercial partners are ongoing to make DOPTELET available in Europe.”

Safety and efficacy data from two global Phase 3, double-blind, placebo-controlled trials, conducted in adults with thrombocytopenia (platelet count of less than 50,000/µL) and CLD, supported the EC marketing authorization. DOPTELET was shown to be superior to placebo in increasing the proportion of patients not requiring platelet transfusions or rescue procedures for bleeding up to 7 days following a scheduled procedure in both trials and both the 40 mg and 60 mg treatment groups. DOPTELET was also superior to placebo at the two secondary efficacy endpoints in each trial, i.e., the proportion of patients achieving a platelet count equal to or greater than 50,000/µL and the magnitude of the change in platelet counts from baseline to procedure day.

Click here to read the full press release.