Xarelto for stroke prevention gets nod from FDA panel
(CBS/AP) The FDA moved closer to approving Xarelto (rivaroxaban) for the treatment of a heart condition that raises the risk for stroke when an advisory panel for the agency on Thursday green-lighted the anti-clotting drug.
Xarelto is already approved to prevent clots in people who get knee and hip replacements. Its developers, Johnson & Johnson and Bayer, are seeking to have the drug approved for the treatment of the heart rhythm disorder atrial fibrillation (AF).
About 2.2 million Americans, plus 4.5 million people in the European Union, have the condition.
The FDA is expected to make a final decision by early November.
The panel's vote came despite a negative review by FDA staff released two days ago. The FDA staff reviewers wrote that results of a late-stage study of more than 14,000 patients, known by the acronym ROCKET, didn't prove Xarelto is as effective and safe as the standard drug, warfarin (Coumadin).
Patients and doctors have long wanted a better treatment than inexpensive warfarin because it's difficult to maintain the correct dose in the blood. Too much warfarin can cause internal bleeding. Too little can cause stroke.
The American Heart Association has been advocating the approval of Xarelto.
"For the millions of patients with atrial fibrillation, stroke is a real health threat, and the emerging studies of new anticoagulant drugs like rivaroxaban has been very encouraging," the association's president, Dr. Gordon Tomaselli, said in a written statement. "However, it's too soon to predict the overall impact that rivaroxaban or similar drugs will have on patients until these new drugs are used more widely."
A daily pill, Xarelto works by blocking a clotting protein. Older blood thinners, including warfarin, work by preventing platelets from sticking together.
Patients taking warfarin need frequent blood tests to ensure they're getting the right dose.
That's made an easier-to-use alternative a key goal of several drugmakers. Last October, the FDA approved the first warfarin alternative for atrial fibrillation - Pradaxa (dabigatran), made by the German company Boehringer Ingelheim.
Another new drug, Eliquis, developed by Bristol-Myers Squibb and Pfizer, was approved in the 27 European Union countries on May 20. The companies plan to seek U.S. approval later this year.
WebMD has more on atrial fibrillation.
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