Eliquis wins regulatory approvals in U.S., Japan

The end of the year has proved to be joyous for Bristol-Myers Squibb and Pfizer, whose anticlotting drug apixaban (Eliquis) received back-to-back approvals by the FDA in the U.S. and the Ministry of Health, Labor and Welfare in Japan.

The FDA approved Eliquis on Dec. 28, 2012, with the indication to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF). The approval came two days after Japan approved the oral direct factor Xa inhibitor for the same indication, and within months of approval in Canada and the European Union.

The safety and efficacy of Eliquis in treating patients with AF not caused by cardiac valve disease were studied in two clinical trials. ARISTOTLE results showed that apixaban was superior to warfarin in reducing stroke and systemic embolism in AF patients. AVERROES demonstrated that apixaban reduced the risk of stroke or systemic embolism by more than 50 percent in AF patients who were deemed unsuitable to receive vitamin K antagonists without increasing the risk of major bleeding or intracranial hemorrhage.

However, patients in the U.S. with prosthetic heart valves should not take Eliquis nor should patients with AF that is caused by a heart valve problem, according to the product labeling. These patients were not studied in clinical trials. As with other FDA-approved anticlotting drugs, bleeding—including life-threatening and fatal bleeding—is the most serious risk with Eliquis. There is no agent that can reverse the anticoagulant effect of Eliquis.

Eliquis will be dispensed in the U.S. with a patient Medication Guide that provides instructions on its use and drug safety information. Healthcare professionals should counsel patients on signs and symptoms of possible bleeding.

The approval process was drawn out in the U.S. The FDA first assigned it priority review designation in November 2011 with an action date of March 28, 2012. In March, the FDA assigned new goal date of June after the agency requested additional information on data management and verification from the ARISTOTLE trial. Princeton, N.J.-based Bristol-Myers and New York City-based Pfizer reported Sept. 26 that the FDA acknowledged receipt of a New Drug Application resubmission. The FDA then had set a goal date of March 17 for its review.

The application for Eliquis for the prevention of ischemic stroke and systemic embolism was submitted in Japan on Dec. 21, 2011.