The FDA has granted Fast Track designation to South San Francisco-based Portola Pharmaceuticals’ betrixaban for extended-duration prevention of venous thromboembolism (VTE), or blood clots, in acute medically ill patients (i.e., those who are hospitalized for serious medical conditions such as heart failure, stroke, infection and pulmonary disease). Betrixaban is an investigational oral anticoagulant that directly inhibits the activity of Factor Xa, an important validated target in the blood coagulation pathway, to prevent life-threatening thrombosis.
Portola currently is evaluating betrixaban in the global, pivotal, 7,500-patient phase III APEX (Acute Medically Ill VTE Prevention with Extended Duration Betrixaban) Study for the prevention of VTE in acute medically ill patients. The company expects to complete patient enrollment in APEX by the end of 2015 and report top-line data in the first quarter of 2016. If the trial is successful, the company expects to submit an NDA later in 2016 under the Fast Track designation.
The FDA’s Fast Track process is designed to facilitate the development and expedite the review of drugs used to treat serious conditions and fill an unmet medical need. Fast Track designation enables a company to have early and frequent communication with the FDA throughout the drug development and review process, often leading to earlier drug approval.
“FDA’s Fast Track designation of betrixaban recognizes the unmet medical need in the prevention of VTE in acute medically ill patients. Importantly, it raises public awareness of this life-threatening condition in a large, underserved patient population. Betrixaban has the potential to become the first anticoagulant approved for extended-duration prevention of VTE,” said John Curnutte, M.D., Ph.D., executive vice president, research and development, for Portola. “We’re now focused on completing the APEX trial and reporting results in early 2016.”