Pfizer and Bristol-Myers Squibb submit drug application

Brystol-Myers Squibb company and Pfizer inc announced the FDA has accepted a new drug application for the drug ELIQUIS®. The compound is intended for stroke and systemic embolism prevention in patients with atrial fibrillation. Submissions were based on the Phase 3 trials ARISTOTLE and AVERROES, the largest completed clinical development program for stoke prevention in atrial fibrillation. The trials were comprised of 24,000 patients who were eligible either for anticoagulant therapy or patients who were ineligible for vitamin K antagonist therapy, and demonstrated the efficacy and safety of ELIQUIS®. The results of the application will be made available by the FDA on March 28, 2012.

SOURCE: Pfizer Press Release