Bristol-Myers Squibb Company and Pfizer Inc. have announced that the European Commission (EC) has approved Eliquis for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults.
Bristol-Myers Squibb Company and Pfizer Inc. have announced that the European Commission (EC) has approved Eliquis for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and the prevention of recurrent DVT and PE in adults.
EC approval applies to all European Union (EU) member states, as well as Iceland and Norway. Eliquis is also approved in the EU for the prevention of venous thromboembolism (VTE) in adults who have undergone elective total hip- or knee-replacement surgery, and for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors.
“Every year, approximately one million patients in the EU are diagnosed with VTE,” said Dr 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 authorisation for Eliquis follows the positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, and is supported by two pivotal phase III clinical trials, Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY (AMPLIFY) and Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended treatment (AMPLIFY-EXT). The former was designed to demonstrate the efficacy and safety of Eliquis for the treatment of DVT and PE versus enoxaparin 1mg/kg twice daily subcutaneously for at least 5 days (until international normalised ratio [INR] ≥2) and warfarin (target INR range 2.0–3.0) orally for 6 months. The latter was designed to demonstrate the efficacy and safety of Eliquis compared with placebo for the prevention of recurrent DVT and PE following 6 to 12 months of anticoagulant treatment for DVT and/or PE.
“The European Commission’s approval of Eliquis for the treatment of DVT and PE and the prevention of recurrence is an important milestone and demonstrates Bristol-Myers Squibb and Pfizer’s ongoing commitment to bringing innovative medicines to patients who need them,” said Steve Romano, senior vice president, head of Medicines Development Group for Global Innovative Pharmaceuticals, Pfizer Inc.
