Avatrombopag for chronic liver disease

Dova Pharmaceuticals, Inc.has announced the New Drug Application (NDA) for avatrombopag has been accepted for filing and has been granted Priority Review by the FDA. Dova is seeking FDA approval of avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. The submission is based on two identically-designed Phase III clinical trials, ADAPT 1 and ADAPT 2, in which avatrombopag met all primary and secondary endpoints with high statistical significance. The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is 21 May 2018.

Comment: Avatrombopag is a second generation orally administered TPO-RA which is intended to address the limitations of other existing treatments for thrombocytopenia. Avatrombopag is initially being studied for its potential for the acute treatment of thrombocytopenia in patients with CLD scheduled to undergo a procedure. Dova is also planning to explore the potential use of avatrombopag in a broader population of patients with thrombocytopenia, including in patients undergoing surgical procedures associated with a high risk of bleeding, and patients who develop thrombocytopenia after receiving chemotherapy.