Canada Okays a New Drug for Stroke Prevention in People With Atrial Fibrillation

 Health Canada gave the green light for the anticoagulant apixaban (Eliquis) to be used for the prevention of stroke and systemic embolism in patients with atrial fibrillation (Afib).

Apixaban, an oral factor Xa inhibitor, was just approved for the same indication in the European Union.

However, in the U.S., the FDA has postponed its decision on whether to approve the drug for stroke prevention in Afib, requesting additional data.

The Canadian approval of apixaban is based on data from the ARISTOTLE and AVERROES studies, which evaluated almost 24,000 patients. The studies compared apixaban with warfarin and aspirin, respectively, and looked at efficacy relating to stroke and systemic embolism, as well as safety relating to major bleeding as the primary endpoints. All-cause death was the secondary endpoint.

As a class, new oral anticoagulants have been officially recognized by the Canadian Cardiovascular Society (CCS) clinical practice guidelines for stroke prevention in Afib as a preferable option to warfarin, previously considered the standard of care.

Health Canada had previously approved apixaban for the prevention of venous thromboembolic events in adult patients who have already undergone elective knee or hip replacement surgery.