FDA Moves on Rivaroxaban and Apixaban

March 01, 2012

March 1, 2012 (Silver Spring, Maryland) — The FDA has granted priority review to the new oral anticoagulant rivaroxaban (Xarelto, Bayer) for the additional indication of reducing cardiovascular events in patients with acute coronary syndrome, in conjunction with standard antiplatelet therapy [1]. This means the agency will complete its review within six months from the receipt of the supplemental new-drug-application (NDA) submission, rather than the standard 10-month review cycle.

At the same time, the FDA says it will extend by three months the action date for the NDA for apixaban (Eliquis, Pfizer/Bristol-Myers Squibb) for the prevention of stroke and systemic embolism in patients with atrial fibrillation [2]. Apixaban was originally designated priority review for this indication when the NDA was accepted in November 2011. The companies say the extension is because they submitted "additional information about the Eliquis clinical program to the FDA, which constitutes a major amendment to the application and will require additional time for review." The new date for a ruling on apixaban is now June 28, 2012. At this stage, there are no plans for an FDA advisory committee meeting to review apixaban for this indication, they add.

Both rivaroxaban and apixaban are oral factor Xa inhibitors.

Rivaroxaban is already approved in the US for prevention of stroke in AF and for the prevention of deep vein thrombosis prior to hip- and knee-replacement surgery. The application for the supplemental NDA in ACS is based on the results of the ATLAS ACS 2-TIMI 51 study, reported at the AHA meeting at the end of last year. The FDA usually grants priority reviews to drugs that offer advances in care or that provide a treatment where no adequate therapy exists.

Apixaban is not yet approved in the US, nor is it available anywhere for prevention of stroke in AF. But it was approved in the EU last year for the prevention of venous thromboembolic events in adult patients who have undergone elective hip- or knee-replacement surgery.

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