Bristol-Myers Squibb (NYSE: BMY) and Pfizer (NYSE: PFE) announced today that the European Commission has approved ELIQUIS® (apixaban) for prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors. ELIQUIS 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. ELIQUIS is an oral direct Factor Xa inhibitor, part of a novel therapeutic class. This is the first regulatory approval in any market for ELIQUIS for stroke prevention in patients with nonvalvular atrial fibrillation.
"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 nonvalvular atrial fibrillation."
The marketing authorization for ELIQUIS is supported by the pivotal Phase 3 trials ARISTOTLE and AVERROES, which evaluated approximately 24,000 patients with NVAF in the largest completed clinical trial program conducted to date in this patient population. The ELIQUIS clinical program is the only Phase 3 clinical program among the new oral anticoagulants to evaluate the safety and efficacy of ELIQUIS versus aspirin in patients who were unsuitable for vitamin K antagonist (VKA) therapy.
"Today's approval of ELIQUIS in the EU is the result of a strong collaboration between Bristol-Myers Squibb and Pfizer to help address the unmet need for improved treatment options versus warfarin to reduce the burden of stroke in patients with nonvalvular atrial fibrillation," said Lamberto Andreotti, Chief Executive Officer, Bristol-Myers Squibb. "With its compelling clinical profile, ELIQUIS represents the commitment of our partnership with Pfizer to scientific innovation and our shared vision of bringing innovative and meaningful medicines to patients."
"We are confident in ELIQUIS and its differentiated profile and believe it has the potential to transform the standard of care in stroke prevention in nonvalvular atrial fibrillation," said Ian Read, Chairman and Chief Executive Officer, Pfizer. "With our combined cardiovascular leadership and expertise, we believe that we will successfully introduce this important medicine to patients and physicians in the EU."
ELIQUIS 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 (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). ELIQUIS does not require International Normalized Ratio (INR) monitoring and there are no known dietary restrictions.
The first-line use of ELIQUIS and other new oral anticoagulants (NOACs) is recommended in The European Society of Cardiology Guidelines for the management of AF where oral anticoagulation is recommended, recognizing the important benefits that ELIQUIS offers in preventing NVAF-related stroke.