The FDA accepted for review a new drug application (NDA) for the anticoagulant apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) and assigned a priority review designation, the pharmaceutical companies announced Nov. 29. The goal date for issuing a decision is March 28, 2012.
Apixaban is a factor Xa inhibitor developed to prevent stroke and systemic embolism in patients with atrial fibrillation (AF). In a statement, Bristol Myers Squibb and Pfizer said the submission was based on results from two Phase 3 clinical trials, ARISTOTLE and AVERROES. ARISTOTLE found that apixaban reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent and death by 11 percent.
AVERROES results showed that apixaban significantly reduced the risk of stroke or systemic embolism without increasing the risk of major bleeding or intracranial hemorrhage in AF patients. AVERROES was stopped early, based on the beneficial findings.
Apixaban is one of several novel anticoagulants under study as alternatives to warfarin, including direct thrombin inhibitor dabigatran (Pradaxa, Boehringer Ingelheim) and the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare). The vitamin K inhibitor warfarin has been effective at reducing that risk of blood clots but it interacts with other drugs and foods, consequently requiring monitoring and dose adjustments.
The European Medicines Agency approved dabigatran in August for preventing stroke and systemic embolism in non-valvular AF patients; rivaroxaban received FDA approval last month. Apixaban received regulatory approval in May for 27 countries of the European Union for the prevention of venous thromboembolic events in adult patients who received elective hip or knee replacement surgery.