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FDA Grants Dova Pharmaceuticals’ NDA Priority Review

Their decision on the NDA is expected by Spring of 2018

By: Betsy Louda

, Contract Pharma

Dova Pharmaceuticals’ New Drug Application (NDA) for avatrombopag has been granted Priority Review by the United States Food and Drug Administration. The drug is specifically intended 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. 

 

Alex Sapir, president and chief executive officer of Dova, said, “We believe that avatrombopag represents a novel treatment option with robust efficacy as well as an improved safety profile when compared to platelet transfusions, today’s current standard of care. We look forward to working closely with FDA through the review process.”

 

The Prescription Drug User Fee Act (PDUFA) goal date for an FDA decision is May 21, 2018.

 

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