The European Commission has cleared an oral anticoagulant, Eliquis, developed by Bristol-Myers Squibb (BMS) and Pfizer.
Eliquis 5mg, trade name of apixaban in Europe, is indicated as a twice-daily drug for preventing strokes and systemic embolism in nonvalvular atrial fibrillation (NVAF) adult patients.
Oral anticoagulant targets a protein called Factor Xa that plays an essential role in blood clotting and was proven to demonstrate better risk reductions compared to warfarin.
Bristol-Myers Squibb chief executive officer Lamberto Andreotti said, "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."
The approval was based on ARISTOTLE and AVERROES Phase 3 trials that assessed the safety and efficacy of Eliquis against aspirin in NVAF patients unsuitable for vitamin K antagonist therapy.
Eliquis is approved for use in NVAF patients with one or more risk factors including prior stroke or transient ischaemic attack, patients aged 75 years or older, hypertension, diabetes mellitus and symptomatic heart failure.
Pfizer chairman and chief executive officer Ian Read said Eliquis' differentiated profile has the potential to transform the standard of care in stroke prevention in nonvalvular atrial fibrillation.
"With our combined cardiovascular leadership and expertise, we believe that we will successfully introduce this important medicine to patients and physicians in the EU," Read added.
