Bristol-Myers Squibb Company, a global biopharmaceutical company, and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Eliquis (apixaban) be granted marketing authorization for the treatment of DVT (deep vein thrombosis) and PE (pulmonary embolism), and the prevention of recurrent DVT and PE, in adults.
The CHMP’s positive opinion will now be reviewed by the European Commission (EC). The decision on whether to approve Eliquis for this indication will be made by the EC and will be applicable to all European Union member states plus Iceland and Norway.
The positive opinion was based on the results from the pivotal AMPLIFY and AMPLIFY-EXT studies. AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY), a randomized, double-blind, multicenter trial, included 5,395 patients (2,691 were randomized to Eliquis and 2,704 were randomized to standard of care, which was initial enoxaparin treatment overlapped by warfarin therapy) with confirmed symptomatic DVT or PE requiring treatment for six months, and evaluated Eliquis therapy compared to standard of care. The primary efficacy endpoint was the composite endpoint of recurrent symptomatic VTE (nonfatal DVT or nonfatal PE) or VTE-related death. The primary safety endpoint was the incidence of major bleeding compared to standard of care.
AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended Treatment), a randomized, double-blind, multicenter trial, included 2,486 patients (842 were randomized to Eliquis 2.5 mg, 815 were randomized to Eliquis 5 mg and 829 were randomized to placebo) with prior VTE who had completed six to 12 months of anticoagulation treatment for DVT or PE, and evaluated Eliquis therapy compared to placebo. The primary efficacy endpoint was reduction of the composite of symptomatic, recurrent VTE and death from any cause. The primary safety endpoint was the incidence of major bleeding.
Venous thromboembolism, or VTE, encompasses two serious conditions: deep vein thrombosis (DVT), a blood clot in a deep vein, usually in the lower leg, thigh, or pelvis, which partially or totally blocks the flow of blood; and pulmonary embolism (PE), a blood clot that blocks one or more vessels in the lungs. Approximately one million patients in the EU are diagnosed every year with VTE. In the US, the number of adults with VTE is projected to more than double from 0.95 million in 2006 to 1.82 million in 2050. Once a VTE has occurred, up to 10 per cent of people may have a VTE reoccurrence, which could potentially be fatal.
Eliquis (apixaban) is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, Eliquis decreases thrombin generation and blood clot formation. Eliquis is approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the United States, European Union, Japan and a number of other countries around the world. Eliquis is approved for the prophylaxis of DVT which can lead to PE in adult patients who have undergone elective hip or knee replacement surgery in the United States, European Union and a number of other countries around the world. Eliquis is not approved for this indication in Japan.
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb's long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.