Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) today announced that the European Commission has approved Eliquis for the treatment of DVT and PE, and the prevention of recurrent DVT and PE in adults. The European Commission 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 authorization 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 3 clinical trials, AMPLIFY and AMPLIFY-EXT. AMPLIFY ( Apixaban for the initial Management of Pu Lmonary embol Ism and deep vein thrombosis as First-line therap Y) was designed to demonstrate 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 (until INR≥ 2) and warfarin (target INR range 2.0-3.0) orally for six months. AMPLIFY-EXT ( Apixaban after the initial Management of Pu Lmonary embol Ism and deep vein thrombosis with First-line therap Y-EXTended treatment) 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.
“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.About the Clinical Trial Program AMPLIFY As described in the SmPC, in the AMPLIFY study a total of 5,395 patients were randomized to treatment with Eliquis 10 mg twice daily orally for seven days followed by Eliquis 5 mg twice daily orally for six months, or enoxaparin 1 mg/kg twice daily subcutaneously for at least five days (until INR≥ 2) and warfarin (target INR range 2.0-3.0) orally for six months. The mean age was 56.9 years and 89.8 percent of randomized patients had unprovoked VTE events.