Bristol-Myers/Pfizer's Eliquis gets EU backing for stroke prevention and NVAF

US drug major Bristol-Myers Squibb (NYSE: BMY) and partner Pfizer (NYSE: PFE), the world’s largest drugmaker by sales, have gained European Commission approval for Eliquis (apixaban) for prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors.

The companies say that 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 the product for stroke prevention in patients with non-valvular atrial fibrillation.

The news came the same day that rival Bayer gained approved in the European Union for its oral anticoagulant Xarelto (rivaroxaban) for the treatment of pulmonary embolism (PE) and the prevention of recurrent deep vein thrombosis (DVT) and PE in adults (The Pharma Letter November 21).