Bristol-Myers Squibb and Pfizer have announced the European Commission’s approval of Eliquis, an oral selective Factor Xa inhibitor, to treat deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as prevention of recurrent DVT and PE in adults.
The European Commission approval applies to all EU member states, as well as Iceland and Norway.
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In the EU, Eliquis is also cleared to prevent venous thromboembolism in adults who have undergone elective total hip or knee replacement surgery, and to prevent stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation with one or more risk factors.
Pfizer Global Innovative Pharmaceuticals Medicines Development Group head and senior vice-president Steve Romano said: “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.”
The EU approval of Eliquis is supported by two pivotal Phase III clinical trials, AMPLIFY (Apixaban for the initial Management of PuLmonary embolIsm and deep vein thrombosis as First-line therapY) and AMPLIFY-EXT (Apixaban after the initial Management of PuLmonary embolIsm and deep vein thrombosis with First-line therapY-EXTended treatment).
AMPLIFY was designed to demonstrate the safety and efficacy of Eliquis for the treatment of DVT and PE compared to enoxaparin 1mg/kg twice daily subcutaneously for at least five days and warfarin orally for six months.
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By GlobalDataAMPLIFY-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.
Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration in 2007 to develop and commercialise apixaban, discovered by Bristol-Myers Squibb.
