The U.S. FDA granted priority review to Portola Pharmaceuticals Inc.'s new drug application for betrixaban.
Betrixaban, an FDA-designated fast track investigational drug, is a Factor Xa inhibitor anticoagulant for extended-duration prophylaxis of venous thromboembolism in acute medically ill patients with risk factors for venous thromboembolism.
A priority review shortens the agency's review timeline to six months from the standard review period of 10 months. The application for the drug was deemed sufficiently complete to allow a substantive review and was given an approval date of June 24, 2017.
In addition, the European Medicines Agency has validated Portola's marketing authorization application for betrixaban. The EMA's committee for medicinal products for human use is reviewing the application under a standard 210-day review period.