FDA accepts Eliquis for review
NEW YORK and PRINCETON, N.J. — A drug designed to prevent stroke and systemic embolism in patients with atrial fibrillation has been accepted for review by the Food and Drug Administration.
Bristol-Myers Squibb and Pfizer said their investigational compound Eliquis (apixaban) was accepted for review and granted a priority-review designation. The companies submitted the application to the agency after completing two phase-3 trials, which examined the efficacy and safety of Eliquis among about 24,000 patients.
The Prescription Drug User Fee Act goal for the drug is set for March 28, 2012.