ParagonRx® | Minimize Risk and Optimize Use

The FDA accepted and assigned priority review status to Bristol-Myers Squibb and Pfizer's marketing application seeking approval of Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF), the companies said Tuesday. The regulator set a target date of March 28 for completing its review of the filing.

According to the drugmakers, the submission is based on results of the late-stage ARISTOTLE and AVERROES studies, which investigated the oral anticoagulant for the prevention of stroke or systemic embolism in approximately 24 000 patients with AF. The trials included patients eligible for anticoagulant therapy based on current treatment guidelines, as well as those expected or demonstrated to be unsuitable for vitamin K antagonist therapy.

Bristol-Myers Squibb and Pfizer noted that as previously reported, an application for Eliquis for stroke prevention in AF has been validated for review by the European Medicines Agency. The agent was approved earlier this year in the EU for use in preventing venous thromboembolic events in adults who have undergone elective hip or knee replacement surgery.

[Link to article]