Betrixaban filed with FDA for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients- Portola Pharmaceuticals

Portola Pharmaceuticals has submitted a New Drug Application to the FDA seeking approval to market betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. Betrixaban, an FDA Fast Track-designated investigational drug, is an oral, once-daily Factor Xa inhibitor anticoagulant.

The NDA for betrixaban is supported by data from the pivotal Phase III APEX Study, which enrolled 7,513 patients at more than 450 clinical sites worldwide and assessed the superiority of extended-duration anticoagulation with oral betrixaban for 35 - 42 days compared with standard-duration injectable enoxaparin for 10+4 days in preventing VTE in high-risk acute medically ill patients. Results showed that betrixaban reduced the incidence of VTE compared with enoxaparin at a p value approaching statistical significance in the primary efficacy analysis subgroup of 3,870 patients with elevated D-dimer levels. It also significantly reduced VTE in several pre-specified analyses of the primary efficacy analysis subgroup as well as in the overall study population of 7,513 patients. No statistical difference in major bleeding was observed between the betrixaban and enoxaparin arms in either of the primary analysis patient subgroup or in the overall study population.

Comment: Portola expects a response from the FDA within 60 days as to whether the NDA is complete and acceptable for filing. The Company plans to submit a Marketing Authorization Application for approval of betrixaban in the EU by the end of this year.