Eliquis, the blood thinner sold by Pfizer Inc. and Bristol-Myers Squibb Co., was as good as the current standard of care in preventing blood clots and with fewer bleeding complications, according to a study.
In a trial of 5,400 people, the drug was found to be equivalent to the generic warfarin at preventing new clots and death in patients who had a venous thromboembolism, or VTE. In VTE, clots form in the body’s large arteries, often in the legs or pelvis. The clots can then break off and travel into the lungs, causing a potentially deadly pulmonary embolism.
Eliquis is one of three in a new class of blood thinners that may replace warfarin, a half-century old therapy that needs regular monitoring and requires patients to avoid certain foods. Bristol-Myers and Pfizer will use the results of the study to apply to regulators for using Eliquis in short- and long-term treatment of VTE. It’s already approved for stroke prevention in patients with irregular heartbeat.
“We have data to support a real change in clinical practice,” said Giancarlo Agnelli, a professor of internal medicine at Italy’s University of Perugia who led the trial. Current therapy “has some limitations,” he said. With Eliquis, “we have a new compound and a new way to give it that’s much, much easier.”
Bristol-Myers and Pfizer, both based in New York, sponsored the trial. It is being published in the New England Journal of Medicine and presented at the Congress of the International Society on Thrombosis and Haemostasis in Amsterdam.
Pfizer shares fell less than 1 percent to $27.78 at the close in New York. Bristol-Myers rose less than 1 percent to $44.82.
Patients in the study were given Eliquis or warfarin for six months after being diagnosed with a VTE that came on suddenly, instead of from an expected cause such as surgery or childbirth. Of the patients on Eliquis, 2.3 percent died or had another clot, compared with 2.7 percent on warfarin. The warfarin patients also typically received heparin, another blood thinner typically given in a hospital, in the early part of treatment.
“This population is of very high risk of recurrence,” Agnelli, referring to a deep-vein thrombosis, said in a telephone interview. “If you have deep-vein thrombosis after surgery, the recurrence rate is much lower.”
Eliquis was better than warfarin in terms of safety, the trial also found. In the study, 0.6 percent of patients on Eliquis had major bleeding -- for example inside the eye, skull, gastro-intestinal tract or in other major organs -- compared with 1.8 percent of patients on warfarin.
Xarelto, a competing drug sold by Leverkusen, Germany-based Bayer AG and New Brunswick, New Jersey-based Johnson & Johnson, already is approved for VTE. Boehringer Ingelheim’s Pradaxa, also one of the new wave of blood thinners, isn’t yet approved in the U.S. for VTE.
New treatments for VTE can help save money because they can shorten the time patients are taking the heparin, often the first treatment they get before warfarin, and staying in the hospital, said Seamus Fernandez, an analyst with Leerink Swann & Co. “Venous thrombosis treatment with Xarelto is a big cost-saver for hospitals, driving incremental access and uptake,” he said in an April 5 note to clients. “Success in VTE treatment could be a major boon to BMY/PFE’s Eliquis,” Fernandez said.
From 300,000 to 900,000 people in the U.S. have a venous thromboembolism each year, according to the Centers for Disease Control and Prevention in Atlanta. About half of those occur after a hospital stay or surgery, according to the CDC.