–Generally positive results for Portola’s betrixaban, despite missed key endpoint Betrixaban may yet become the first new oral anticoagulant to gain approval for extended venous thromboembolism (VTE) prophylaxis in the important and underserved group of medically-ill patients, even though its pivotal trial was damaged by a self-inflicted statistical wound. There were consistent differences in favor of…
A highly promising novel anticoagulant system now appears to be in serious difficulty. Regado Biosciences announced today that the FDA had placed a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation system. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant effect. REGULATE-PCI is a phase 3…
Filed Under: Interventional Cardiology & Surgery, People, Places & Events, Policy & Ethics Tagged With: anticoagulants, FDA, Regado Biosciences, The Medicines Company