Regulators have given the green light to allow use of Bristol-Myers Squibb/Pfizer’s anticoagulant Eliquis to reduce the risk of blood clots following hip or knee replacement surgery.
The US Food and Drug Administration has approved a supplemental New Drug Application for Eliquis (apixaban) for the prevention of deep vein thrombosis, which may lead to pulmonary embolism in patients who have undergone either of the aforementioned surgeries. The oral Factor Xa inhibitor is already available for reducing the risk strokes in patients with atrial fibrillation and the sNDA approval is supported by three clinical trials which randomised more than 11,000 patients, with 5,770 receiving Eliquis and 5,755 receiving enoxaparin.
B-MS and Pfizer noted that each year in the USA, an estimated 719,000 total knee replacement surgeries and 332,000 hip replacement surgeries are performed. Steven Romano, head of Pfizer’s medicines development group, said that as the number of these surgeries continues to increase, “the risk of DVT following these surgeries remains a concern for physicians”. He added that Eliquis is a new treatment option that offers twice-daily oral dosing “and no routine coagulation testing, and is broadly accessible through hospitals and managed healthcare formularies” in the USA.
This latest thumbs-up will help Eliquis compete more closely with Xarelto (rivaroxaban), Bayer and Johnson & Johnson’s Factor Xa inhibitor which was approved for orthopedic surgery back in 2011 and is taken once a day. The latter is also available for the stroke indication.
