Johnson & Johnson (JNJ) and Bayer AG (BAYN), makers of stroke preventative Xarelto, won U.S. Food and Drug Administration approval for wider use of the medicine to treat blood clots in the legs and lungs and stave off recurrences.
Bleeding, the major side effect with the blood thinner, is similar to other anti-clotting drugs, the FDA said today in a statement. Xarelto can now be used to treat clots from deep vein thrombosis in the legs, which can travel to the lungs and block an artery, a condition called pulmonary embolism that kills 30 percent of sufferers, the National Institutes of Health said.
The leg and lung clots can affect as many as 600,000 people in the U.S. each year and together are known as venous thromboembolism. Xarelto’s use in lung and leg clots may account for $600 million of a projected $4.2 billion in peak annual sales of the medicine, Jeffrey Holford, an analyst at Jefferies Group Inc. in New York, said in an e-mail.
“Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago,” Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s drug evaluation center, said in the statement.
Xarelto was approved a year ago to prevent strokes in patients with irregular heart rhythms and in July 2011 to reduce the risk of leg and lung clots after knee and hip surgery. It competes with Boehringer Ingelheim GmbH’s Pradaxa in stroke prevention.
Patients with lung clots typically are treated with the fast-acting injected drug enoxaparin. After 5 to 10 days, they begin taking the anticoagulant warfarin to prevent future blood clots. Warfarin, available as a generic drug, has been used for more than five decades and requires regular blood tests to ensure people are getting an appropriate dose.
Patients who took Xarelto experienced fewer new clots in the legs or lungs than those who took standard therapy, according to a trial conducted by New Brunswick, New Jersey- based J&J and Leverkusen, Germany-based Bayer.
“Venous blood clots are associated with a high risk of serious complications, so the approval of Xarelto will immediately impact how we treat these patients and may set a new standard of care,” Jack Ansell, professor of medicine at New York University School of Medicine, said in a statement from J&J.
The FDA declined in June to approve Xarelto to prevent heart attacks and strokes in patients with serious chest pain or a previous heart attack, a condition known as acute coronary syndrome. Missing clinical trial information made it difficult to interpret the data for Xarelto’s use for the wider group of heart patients, advisers to the FDA said.
J&J responded to the FDA in September and may hear the agency’s decision in March based on the new data.
Pfizer Inc. (PFE) and Bristol-Myers Squibb Co. (BMY), both based in New York, are awaiting an FDA decision also in March on their experimental Eliquis to reduce the risk of stroke in patients with irregular heartbeat.
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