The European Commission has approved apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors. This is the first regulatory approval in any market for apixaban on this indication.
According to a company release, apixaban is the only oral anticoagulant that has demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding, and all-cause mortality.
“Patients with atrial fibrillation have a five times greater risk of stroke and there remains a critical public health need for improved treatment options to reduce this risk,” said Lars Wallentin, director and professor of Cardiology, Uppsala Clinical Research Centre and University Hospital, Sweden. “The approval of Eliquis represents an important new treatment option for health care professionals, who now have an oral anticoagulant with superior outcomes versus warfarin in the reduction of stroke, major bleeding and death in patients with non-valvular atrial fibrillation.”
The European approval for apixaban is supported by the pivotal phase 3 trials ARISTOTLE and AVERROES, which evaluated approximately 24,000 patients with non-valvular atrial fibrillation in the largest completed clinical trial programme conducted to date in this patient population. The apixaban clinical programme is the only phase 3 clinical programme among the new oral anticoagulants to evaluate the safety and efficacy of apixaban versus aspirin in patients who were unsuitable for vitamin K antagonist (VKA) therapy.
Eliquis 5mg is indicated as a twice-daily oral medication for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Apixaban does not require international normalised ratio (INR) monitoring and there are no known dietary restrictions.
The first-line use of apixaban and other new oral anticoagulants is recommended in the European Society of Cardiology Guidelines for the management of atrial fibrillation where oral anticoagulation is recommended.