Pfizer And BMS Receive CHMP Recommendation For Eliquis In DVT/PE
Pfizer together with its partner Bristol-Myers Squibb report that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Eliquis’ (apixaban) marketing authorization as treatment of DVT (deep vein thrombosis) and PE (pulmonary embolism), and for the prevention of recurrent DVT and PE, in adult patients in the EU.
The CHMP opinion of Eliquis was based on results from the pivotal 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) trials. In both trials, Eliquis demonstrated efficacy in the reduction of recurrent symptomatic VTE or VTE related death. The primary safety endpoint in both trials was the incidence of major bleeding compared to standard of care.
Eliquis (apixaban) is an oral selective Factor Xa inhibitor that decreases thrombin generation and blood clot formation. The drug has received regulatory approval to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the prophylaxis of DVT, which can lead to PE in adult patients who have undergone hip or knee replacement surgery. Bristol-Myers Squibb and Pfizer entered into collaboration in 2007 to co-develop and commercialize apixaban, which was discovered by BMS.
Venous thromboembolism involves two serious conditions. The first is deep vein thrombosis, wherein a blood clot in a deep vein usually in the lower extremities of the body partially or totally blocks blood flow. The second is pulmonary embolism, where a blood clot blocks one or more blood vessel in the lungs. An estimated one million patients in the EU are diagnosed with VTE every year, up to 10 percent of which may suffer or face the threat of death from VTW reoccurrence.
The European Commission is expected to make a decision for the approval of Eliquis a few months after the CHMP issues recommendation.