Apixaban inches closer to EU approval for VTE prevention

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The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion March 17, recommending the granting of a marketing authorization for Eliquis (Pfizer/Bristol-Myers Squibb) 2.5 mg film-coated tablet intended for the prevention of venous thromboembolic events (VTE) in adult patients, who have undergone elective hip or knee replacement surgery.

The active substance of Eliquis is apixaban, a reversible direct and selective inhibitor of factor Xa, which inhibits free and clot-bound factor Xa and prothrombinase activity, leading to indirect inhibition of platelet aggregation induced by thrombin.

According to CHMP, the benefits with Eliquis are its ability to exert anticoagulant properties and demonstrate antithrombotic activity in the prevention of venous thromboembolism. The most common side effects are anemia, hemorrhage, contusion and nausea.

CHMP, on “the basis of quality, safety and efficacy data submitted, considers there to be a favorable benefit to risk balance for Eliquis and therefore recommends the granting of the marketing authorization.”

A CHMP positive opinion is necessary in gaining marketing approval by a committee of the European Commission, which has 67 days from the date of the CHMP opinion to grant authorization.