Pfizer and Bristol-Myers Squibb receive EU approval for Eliquis

Pfizer and Bristol-Myers Squibb have announced that the European Commission has approved their drug Eliquis for a new indication.

The treatment has been ratified for use in the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors, based on positive data from clinical trials.

To date, it is the only oral anticoagulant to have demonstrated superior risk reduction versus warfarin in the three important outcomes of stroke and systemic embolism, major bleeding and all-cause mortality.

Eliquis has been available in the EU since May 2011 and is also indicated for the prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.

Ian Read, chairman and chief executive officer of Pfizer, said: "With our combined cardiovascular leadership and expertise, we believe that we will successfully introduce this important medicine to patients and physicians in the EU."

Earlier this month, the companies announced plans to develop an antidote for Eliquis and other Factor Xa inhibitor therapies, addressing concerns over the infrequent but serious bleeding events sometimes associated with this type of drug.