Dova Pharmaceuticals announces FDA acceptance of the avatrombopag new drug application with priority review

Dova Pharmaceuticals

27 November 2017 - Dova Pharmaceuticals today announced the new drug application for avatrombopag has been accepted for filing and has been granted priority review by the United States FDA. 

Dova is seeking FDA approval of avatrombopag for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure. The submission is based on two identically-designed Phase 3 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 goal date for an FDA decision is 21 May 2018.

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , US , Dossier