Pfizer/Bristol Anticoagulant Eliquis Granted New FDA Indication
By Cyndi Root
Bristol-Myers Squibb Company and Pfizer Inc. announced in a press release that the Food and Drug Administration (FDA) has approved Eliquis for a new indication, the prevention of deep vein thrombosis (DVT) in people undergoing hip or knee replacement surgery. The medication was approved in a Supplemental New Drug Application (sNDA). Steven J. Romano, M.D., senior vice president at Pfizer Inc. said, “Eliquis provides patients and physicians with a new treatment option that offers twice daily oral dosing and no routine coagulation testing, and is broadly accessible through hospitals and managed health care formularies.”
Deep Vein Thrombosis
Deep vein thrombosis (DVT) is a blood clotting disorder that occurs when blood clots form and block veins. Most clots occur in the lower body. People are especially susceptible to DVT when undergoing knee or hip replacement surgeries. These types of surgeries are increasing according to Dr. Romano. When blood clots form, the patient is more susceptible to pulmonary embolism (PE). A blood clot breaks off and may travel to the lungs, causing serious injury to the lungs and other organs, and increasing the risk of sudden death.
Eliquis
Eliquis (apixaban) was approved in 2012 for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The FDA accepted the Eliquis sNDA for review in December of 2013. Eliquis inhibits Factor Xa, a clotting protein, decreasing thrombin generation and clot formation. The new approval was based on positive clinical trials. The ADVANCE study included three trials and over 11,000 patients. The ADVANCE-2 study found that 2.5 mg of apixaban twice daily administered after knee replacement was more effective than enoxaparin, without increasing the risk of bleeding.
Bristol-Myers Squibb and Pfizer
Bristol-Myers Squibb and Pfizer began to collaborate on Eliquis in 2007. The companies announced the venture via press release. The partnership to develop the anticoagulant takes advantage of Pfizer’s global reach and Bristol-Myers Squibb’s cardiovascular expertise. Under the terms of the agreement, Pfizer made an upfront payment, will partially fund development costs, and will make milestone payments to Bristol-Myers Squibb. The two companies have a separate agreement to develop and market other ingredients, compounds, and finished drug agents for a variety of conditions including obesity, diabetes, and other metabolic disorders.