Anticoagulant apixaban gets nod for stroke prevention in EU

The European Commission has approved apixaban for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (AF) with one or more risk factors.

Apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) is an oral anticoagulant. Two clinical trials—ARISTOTLE and AVERROES—demonstrated apixaban’s superior risk reduction compared with warfarin. ARISTOTLE results showed that apixaban was superior to warfarin in reducing stroke and systemic embolism in AF patients, while AVERROES results found that apixaban reduced the risk of stroke or systemic embolism by more than 50 percent in AF patients who were deemed unsuitable to receive vitamin K antagonists without increasing the risk of major bleeding or intracranial hemorrhage.

Apixaban 5 mg is indicated as a twice-daily oral medication for prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as prior stroke or transient ischaemic attack; age of 75 years or older; hypertension; diabetes mellitus; or symptomatic heart failure. Apixaban does not require International Normalized Ratio monitoring and there are no known dietary restrictions.

The first-line use of apixaban and other new oral anticoagulants is recommended in European Society of Cardiology Guidelines for the management of AF where oral anticoagulation is recommended.  

In 2011, apixaban received regulatory approval in the 27 EU countries for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery. It has yet to be approved for any indication in the U.S.