NDA Under Priority Review for Thrombocytopenia in Chronic Liver Disease

A Prescription Drug User Free Act (PDUFA) date has been set for May 21, 2018.

Dova Pharmaceuticals announced that its New Drug Application (NDA) for avatrombopag has been accepted for filing and has been granted Priority Review.

Avatrombopag is a second generation oral thrombopoietin receptor agonist which is intended to address limitations of existing treatments for thrombocytopenia. Initially, the Company is seeking Food and Drug Administration (FDA) approval to treat patients with chronic liver disease (CLD) who are scheduled to undergo a procedure. 

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The submission was based on results from ADAPT 1 and ADAPT 2, two identical Phase 3 trials that evaluated avatrombopag vs. placebo in reducing the need for platelet transfusions in patients with CLD undergoing procedures. Results demonstrated how significantly greater proportions of avatrombopag-treated patients across cohorts did not require platelet transfusion after randomization and up to 7 days following an elective procedure compared to placebo. The studies highly statistically significantly met all primary and secondary endpoints.

“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,” said Alex Sapir, President and CEO of Dova.

A Prescription Drug User Free Act (PDUFA) date has been set for May 21, 2018. 

For more information visit Dova.com.