Apixaban may soon be available to European patients to reduce the risk of stroke or systemic embolization associated with nonvalvular atrial fibrillation following a positive review from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)

The decision was based on results from about 24 000 patients in the ARISTOTLE and AVERROES trials. However, the drug's regulatory status for this indication in the US remains in limbo. This summer, the FDA requested more information from Bristol-Myers Squibb and Pfizer about the "data management and verification" in the ARISTOTLE trial. The specifics of the FDA's inquiry have not been made public.

Moreover, only few data were published about bleeding complications, and the related mortality. Indeed, anticoagulation monitoring remains a challenge with this new agent and reversal options need to be evaluated.

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