Johnson & Johnson said Friday that it has given the Food and Drug Administration additional data on its new anti-clotting drug, in a second attempt to get approval for more uses.
Xarelto already is approved for three uses: for reducing risk of blood clots in people who’ve had knee replacement surgery or hip replacement surgery and for reducing stroke risk in people with a common irregular heart rhythm, atrial fibrillation, not caused by a heart valve problem.
It’s part of a new generation of blood thinners seen as big money makers by analysts and the pharmaceutical industry, and viewed by doctors and patients as possible improvements over the long-time standard, warfarin. Warfarin, sold under brands including Coumadin, is inexpensive but requires frequent blood tests to get the dosage right to prevent dangerous internal bleeding.
J&J has been seeking approval to market Xarelto for preventing a second heart attack or stroke in patients at high risk because of a narrowed heart artery, and for preventing blood clots from forming around stents, tiny metal-mesh scaffolds that prop open heart arteries after they have been unblocked.
The FDA turned down the company’s application for the first use in June. That was shortly after agency advisers expressed concerns about bleeding side effects in some study patients and said they didn’t have enough information to accurately gauge the benefits of Xarelto. J&J withdrew the other application a few weeks later.
The company, based in New Brunswick, N.J., said Friday that it has sent the FDA data from a huge study showing Xarelto, a pill known chemically as rivaroxaban, prevented strokes, heart attacks and deaths.
The 15,526-patient study found that adding Xarelto to a low-dose aspirin and a second standard drug reduced those cardiac risks by an additional one-sixth to one-third. The study, called ATLAS, was completed last year.
Johnson & Johnson so far has not reported any sales figures for Xarelto, but said in July that it was among several new products posting strong sales in the second quarter. The company markets Xarelto jointly with Bayer Healthcare.
Xarelto competes with Boehringer Ingelheim’s Pradaxa, which was approved for U.S. sales in late 2010.
Both drugs are very pricey compared to warfarin, which typically costs well under $10 a month, plus $1,600 or more a year for frequent tests of its level in the blood.
Pradaxa, taken twice a day, costs more than $260 per month. Xarelto, taken once a day, costs more than $250 per month. The two new pending uses for Xarelto call for two pills a day, at different dosages and likely a different price.
The drugs’ makers are striving to get more patients on those two drugs before the likely arrival of a third competitor that some analysts have said appears to work better: Eliquis. That drug, developed by partners Bristol-Myers Squibb Co. and Pfizer Inc., was rejected in June by the FDA. The agency is requiring additional information on Eliquis before it will again consider approval.
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