European Commission approves Doptelet for treatment of severe thrombocytopenia – Dova Pharma

Dova Pharmaceuticals, Inc announced that the European Commission (EC) has granted marketing authorization for Doptelet (avatrombopag) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.

Safety and efficacy data from two global Phase III, 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.