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.