European Approval Recommended for Eliquis to Treat and Prevent Recurrence of DVT and PE

June 27, 2014—Bristol-Myers Squibb Company and Pfizer Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending that the companies’ Eliquis (apixaban) be granted marketing authorization for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults. 

The committee’s positive opinion will be reviewed by the European Commission. The decision on whether to approve Eliquis for this indication will be made by the commission and will be applicable to all European Union member states plus Iceland and Norway, advised the companies.

According to the companies, the positive opinion was based on the results from the pivotal AMPLIFY and AMPLIFY-EXT studies. AMPLIFY, which evaluated apixaban for the initial management of PE and DVT, was a randomized, double-blind, multicenter trial composed of 5,395 patients with confirmed symptomatic DVT or PE requiring treatment for 6 months. In the study, 2,691 patients were randomized to Eliquis and 2,704 patients were randomized to the standard of care, which was initial enoxaparin treatment overlapped by warfarin therapy. The results of Eliquis therapy were compared to those of the standard of care. The primary efficacy endpoint was the composite endpoint of recurrent symptomatic venous thromboembolism (VTE; nonfatal DVT or nonfatal PE) or VTE-related death. The primary safety endpoint was the incidence of major bleeding compared to the standard of care.

AMPLIFY-EXT evaluated extended treatment with apixaban after the initial management of PE and DVT with first-line therapy. This randomized, double-blind, multicenter trial included 2,486 patients with previous VTE who had completed 6 to 12 months of anticoagulation treatment for DVT or PE. Of these patients, 842 were randomized to Eliquis 2.5 mg, 815 were randomized to Eliquis 5 mg, and 829 were randomized to a 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, stated Bristol-Myers Squibb and Pfizer.