Johnson & Johnson’s blood thinner Xarelto worked as well as standard treatment in preventing the recurrence of blood clots in the lung with half the risk of severe bleeding, a study found.
The 4,833-patient study, sponsored by J&J and partner Bayer AG (BAYN), found that the new blood thinner could safely and effectively replace a more complicated two-drug regimen used to treat patients suffering symptoms of potentially life- threatening blood clots in the lungs.
The finding, presented at the American College of Cardiology in Chicago today, could add to a lucrative market for Xarelto, approved last year for preventing strokes in patients with irregular heart rhythms. The drug’s use in lung and leg clots could account for $600 million of a projected $4.2 billion in peak worldwide sales of the medicine, according to a March 19 note from analyst Jeffrey Holford of Jefferies Group Inc.
“This is a great result,” said Jack Ansell, chairman of medicine at Lenox Hill Hospital in New York, who wasn’t involved in the study and has done consulting for New Brunswick, New Jersey-based J&J. “It really simplifies therapy for patients.”
U.S. Case Numbers
There are roughly 900,000 cases of such lung and leg clots each year in the U.S., said Ansell. Clots typically start in the legs before moving into the lungs, so the two problems are manifestations of the same disease.
Johnson & Johnson will apply for U.S. approval in the second quarter for treating lung clots, and for deep vein thrombosis, or threatening clots in leg veins, the company said in a statement. Xarelto competes in the stroke-prevention market with Pradaxa from Boehringer Ingelheim GmbH (BING).
“Pulmonary embolism is certainly the ultimate proof of the pudding,” for a blood thinner, said Frank Misselwitz, head of Bayer’s cardiovascular unit, in a telephone interview. “It’s the litmus test. We have a large clot existing; it’s potentially life-threatening. You’re not just preventing a clot but treating it in the initial phase.”
Standard treatment for clots in the lung starts patients on the fast-acting injected drug enoxaparin. After 5 to 10 days, patients go off that drug and continue with the pill warfarin to prevent the condition from recurring. While effective, warfarin is hard to use because regular blood tests are needed to ensure people are getting an appropriate and safe dose.
In the trial, Johnson & Johnson and Leverkusen, Germany- based Bayer tested whether Xarelto could replace both drugs. Patients were randomly assigned to Xarelto or standard therapy. Patients in the Xarelto group took the drug twice a day for the first three weeks, and a slightly higher dose once a day after that for as long as a year.
At the end of the trial, 2.1 percent of patients on Xarelto had experienced new clots in the legs or lungs, including fatal clots, versus 1.8 of those who got standard therapy. These numbers were statistically comparable, according to the findings that are also being published in the New England Journal of Medicine.
Lower Severe Effects
When all meaningful bleeding episodes were counted -- the primary safety measure in the study -- the risk of bleeding was similar in the two regimens. Yet only 1.1 percent of patients on Xarelto had severe hemorrhage, versus 2.2 percent of those on standard therapy.
“We met our objectives,” Harry Buller, lead author on the study and a vascular medicine specialist at the Academic Medical Center in Amsterdam, said in a telephone interview. “It is as good, it is safer and it is much easier to use.”
Pulmonary embolism “is a frightening condition to treat; patients are often petrified and short of breath,” Paul Burton, a former surgeon and J&J vice president, said in an interview. If approved for lung clots, Xarelto could “become a new standard of care.”
Pradaxa isn’t approved yet for lung clots, Reinhard Malin, a spokesman for Ingelheim, Germany-based Boehringer, said by telephone today. The drug was tested in leg and lung clot patients in trials that haven’t yet been submitted for regulatory approval, Malin said.
Boehringer is analyzing the data now and deciding whether to seek approval, he said. Pradaxa is approved in Europe for clot prevention after hip and knee surgery as well as in Europe and the U.S. for stroke prevention.
Bristol Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) are in final-stage trials of blood thinner Eliquis for treating leg or lung clots, MacKay Jimeson, a spokesman for New York-based Pfizer, said in an e-mail. The drug is under U.S. regulatory review for stroke prevention in irregular heart rhythm patients.
In Europe, where Xarelto is already approved for treating leg clots, Bayer will apply for the additional lung clot use in the second quarter, Misselwitz said. Xarelto is also under regulatory review in the U.S. and Europe for treating acute coronary syndrome.
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