Stroke Prevention: FDA Edges Closer To Approving Xarelto Drug
Stroke prevention is making gains, as the FDA edges closer to approving Xarelto (rivaroxaban) for the treatment of a heart condition that raises the risk for stroke.
On Thursday, an advisory panel for the agency gave the anti-clotting drug, which has been advocated by The American Heart Association, the go-ahead, AP reports.
Xarelto, manufactured by Johnson & Johnson and Bayer, is already approved to prevent clots in people who get knee and hip replacements.
The makers are seeking to have the drug approved for the treatment of the heart rhythm disorder atrial fibrillation (AF).
The FDA is expected to reach a final decision by early November, reports AP.
The panel's vote came despite a negative review by FDA staff reviewers released two days ago.
The FDA 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).
For quite some time, patients and doctors have wanted a better treatment than inexpensive warfarin because it's difficult to maintain the correct dose in the blood, AP reports.
Too much warfarin can cause internal bleeding, while too little can cause stroke.
The American Heart Association president, Dr. Gordon Tomaselli, welcomed the study of blood thinning drugs like Xarelto.