Posted by Michael Wonder on 26 Jun 2019
Dova Pharmaceuticals announces European Union marketing authorisation for Doptelet (avatrombopag) for the treatment of thrombocytopenia in patients with chronic liver disease
25 June 2019 - Approval Based on Positive Efficacy and Safety Data from Two Phase 3 Clinical Trials.
Dova Pharmaceuticals today announced that the European Commission 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 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 authorisation.
