CHICAGO—A new drug, Xarelto, is as effective as Coumadin for preventing stroke and blood clots in patients with atrial fibrillation, researchers here at the American Heart Association meeting reported.
Xarelto also had slightly better mortality profile—582 deaths versus 632 in the Coumadin group—but the difference was not statistically significant, according to Dr. Robert Califf of Duke University School of Medicine in Durham, N.C.
The trial randomized 7,111 patients to 20 mg Xarelto daily and 7,125 patients to Coumadin.
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The findings reported here, combined with the observation that Xarelto was as safe and effective Lovenox plus Coumadin in preventing recurrent deep vein thrombosis, may be enough to move the FDA to approve the drug—a process that has been on hold since May, 2009.
In March, 2009 an FDA panel recommended approval of the drug to prevent deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement. The following May, the FDA sent Bayer AG and Johnson & Johnson a complete response letter. According to the companies the FDA did not want additional clinical trials, but did ask for more information.
For the last two months, industry analysts have suggested that "more information" was FDA code for the agency's need to review the results from the atrial fibrillation trial.
The company said is expected to file a formal reply to that complete response letter before the end of the year and submit a "New Drug Application" for stroke prevention in atrial fibrillation at the same time.
In general, the effects of Xarelto on preventing stroke in patients with atrial fibrillation are encouraging—there was no increase in overall bleeding risk and no increase in major bleeding events compared with Coumadin. It's also considered a more patient-friendly drug because it does not require blood tests, a special diet or limits on alcohol intake—all of which are hallmarks of Coumadin therapy.