Dova Pharmaceuticals Inc. announced that its first drug has been submitted with priority review for Food and Drug Administration approval, according to a filing Tuesday with the Securities and Exchange Commission.
The Durham-based pharmaceutical company is seeking approval of its avatrombopag drug, which is used in the treatment of low blood platelet count in individuals with chronic liver disease.
In its Phase 3 clinical trials, the drug met all primary and secondary endpoints with high statistical significance.
The priority review status of the FDA accelerates the review time from ten months to a goal of six months from the date of the acceptance of the filing.
The Prescription Drug User Fee Act goal date for an FDA decision is May 21, 2018.
“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,” said Chief Executive Officer Alex Sapir in a statement.
Sapir has been the CEO since January 2017. Prior to Dova, Sapir was the executive vice president of marketing and sales at United Therapeutics.
Dova stock is currently trading at $28.31, down 32 cents or 1.13 percent for the day.