Dova Pharma to file NDA at FDA in second half of 2018 for avatrombopag to treat immune thrombocytopenic purpura .

Following two separate meetings with the FDA, Dova Pharmaceuticals, Inc. plans to submit a Supplemental New Drug Application (sNDA) in the second half of 2018 for the treatment of patients with immune thrombocytopenic purpura (ITP) and initiate a Phase III clinical trial in the second quarter of 2018 for the treatment of patients with chemotherapy-induced thrombocytopenia (CIT). Results from the previously completed Phase III ITP clinical trial were recently presented on December 10, 2017 at the American Society of Hematology (ASH) meeting.

Comment: In September 2017, Dova Pharmaceuticals Inc. announced the submission of a New Drug Application (NDA) to the FDA for avatrombopag, a second generation orally administered thrombopoietin receptor agonist (TPO-RA) for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure.