NEW YORK CITY (dpa-AFX) - Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) reported that the European Commission or EC has approved Eliquis for the treatment of Deep Vein Thrombosis or DVT and Pulmonary Embolism or PE, and the prevention of recurrent DVT and PE in adults. The EC approval applies to all European Union or EU member states as well as Iceland and Norway. Eliquis is also approved in the EU to prevent venous thromboembolism or VTE in adults who have undergone elective total hip or knee replacement surgery, and to avoid stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation or NVAF with one or more risk factors.
Elliott Levy, senior vice president, head of Specialty Development, Bristol-Myers Squibb. 'Once a VTE has occurred, approximately 33 percent of patients may experience a recurrence within 10 years.'
The marketing authorization for Eliquis follows the positive opinion issued by the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency, and is supported by two Phase 3 trials, AMPLIFY and AMPLIFY-EXT. AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) was designed to show the efficacy and safety of Eliquis for the treatment of DVT and PE versus enoxaparin 1 mg/kg twice daily subcutaneously for at least 5 days and warfarin orally for 6 months. AMPLIFY-EXT was designed to demonstrate the efficacy and safety of Eliquis compared to placebo for the prevention of recurrent DVT and PE following six to 12 months of anticoagulant treatment for DVT and/or PE.
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