FDA does not approve apixaban for stroke prevention in atrial fibrillation

By Professor Juan Tamargo, Madrid, Spain

The US FDA said that more data are required before approving apixaban, an oral factor Xa inhibitor, for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The agency requested additional information on data management and verification from the ARISTOTLE trial.

Apixaban has not been approved for the prevention of stroke or systemic embolism in patients with AF in any country, but is approved in the European Union for prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.

Two large trials, ARISTOTLE and AVERROES, have established the therapeutic profile of apixaban as compared to standard care. The ARISTOTLE trial found apixaban superior to warfarin in preventing stroke or systemic embolism, with less bleeding and lower mortality, which was seen as giving apixaban an edge over dabigatran and rivaroxaban. InAVERROES, apixaban reduced the risk for stroke and systemic embolism vs aspirin alone, without increasing major or intracranial bleeding in patients with AF not considered candidates for warfarin therapy.