Durham-based Dova Pharmaceuticals Applies for FDA Approval for Drug

9/22/17

Dova Pharmaceuticals Inc., which specializes in the development and commercialization of drugs for rare diseases, has submitted its drug avatrombopag for approval to the Food and Drug Administration, according to a Sept. 22 filing with the Securities and Exchange Commission.

The application for avatrombopag was submitted to the FDA after two successful Phase 3 clinical trials.

The drug would be used for the treatment of thrombocytopenia, a condition in which you have a low blood platelet count, in patients with chronic liver disease and who are scheduled to undergo a procedure.

Dova Pharmaceuticals was founded with an initial focus on treating thrombocytopenia, and avatrombopag has become the company’s leading drug candidate.

According to the filing, there is no drug currently approved by the FDA or the European Medicines Agency that treats patients with thrombocytopenia and who have chronic liver disease and are about to undergo a procedure.

Dova is also exploring the possibility of expanding the treatment of thrombocytopenia to patients who are set to undergo surgery and have a high risk of bleeding and patients who developed the disease after undergoing chemotherapy.

Last month, Dova reported a second quarter loss that missed Wall Street expectations in its first quarter as a public company.

Dova went public in late June. The company was formed in March 2016 and has produced no revenue. It posted a loss of $27.2 million in 2016 and a loss of $5.4 million in the first three months of 2017.

Dova’s stock opened at $25.63 a share on Sept. 22, up 26 cents from the previous close.

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