Pfizer, BMS Receive FDA Approval for Additional Indication for EliquisBy
Bristol-Myers Squibb Company and Pfizer Inc. report that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for their anticoagulant Eliquis (apixaban) for treating deep vein thrombosis (DVT) and pulmonary embolism (PE) and for reducing the risk of recurrent DVT and PE following initial therapy.
DVT is a blood clot in a vein, usually in the lower leg, thigh, or pelvis, which partially or totally blocks the flow of blood. PE is a blood clot blocking one or more vessels in the lungs. DVT causes multiple symptoms including pain, swelling, and redness, and more importantly, can progress to PE, which carries the risk of sudden death.
Eliquis is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood-clotting protein. In 2012, Eliquis was approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in the 27 countries of the EU, plus Iceland and Norway, Canada, Japan and the US.
In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an oral anticoagulant discovered by Bristol-Myers Squibb. The two companies share commercialization expenses and profit/losses equally on a global basis.