Portola Pharmaceuticals cleared a U.S. Food and Drug Administration mid-cycle review for its new drug Betrixaban, meaning the drug will not have to go before an advisory committee at this stage.
Betrixaban is an anticoagulant medication used for patients with venous thromboembolism (VTE), the development of blood clots from sitting or lying down for an extended period of time. It is a condition most common in patients dealing with heart or lung failure or who have had a stroke.
“Based on the APEX data, we remain confident in the potential for Betrixaban to be approved as the first anticoagulant for extended duration VTE prophylaxis in high-risk patients,” John Curnutte, executive vice president of research and development at Portola, said. “We look forward to continuing our ongoing discussions with the FDA as part of the priority review process.”
Anticoagulant medicine clears FDA mid-cycle review
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