U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) does not plan to hold an Advisory Committee meeting with Portola Pharmaceuticals for New Drug Application (NDA) for betrixaban, Portola said on Wednesday.
FDA has informed Portola that mid-cycle review for Betrixaban showed no issues that would require an Advisory Committee meeting.
The NDA for betrixaban, a once-daily Factor Xa inhibitor anticoagulant, is under priority review by the FDA for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
John T. Curnutte, M.D., Ph.D., executive vice president, research and development, at Portola said: “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 acute medically ill patients.”