FDA Informs Portola Pharmaceuticals at Mid-Cycle Review for Betrixaban That It Has Not Identified Issues that Require an Advisory Committee Meeting

Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) has informed the Company, as part of its mid-cycle review, that it does not plan to hold an Advisory Committee meeting for Portola’s New Drug Application (NDA) for betrixaban. Betrixaban is an oral, once-daily Factor Xa inhibitor anticoagulant. The NDA for betrixaban, an FDA Fast Track-designated therapy, 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.