A new blood thinner that prevents strokes and dangerous blood clots in patients with atrial fibrillation, a type of heart rhythm disorder, has been approved by the Food and Drug Administration advisory panel.
The panel members cast a vote in order to finalize the FDA's approval.
The panel determined that Xarelto (rivaroxaban) from Johnson and Johnson and Bayer AG was at least as safe and effective as an older drug, warfarin, which is also sold under the brand names Coumadin and Jantoven, reports webmd.com.
The discussion by the panel was based on the findings of the ROCKET-AF study, the results of which were published last month in The New England Journal of Medicine.
Xarelto is among the first of a new class that might be replacing decades-old warfarin.
Having treated thousands of patients with atrial fibrillation and dealt with the tremendous problems of using warfarin and patients having issues with warfarin, I think there's a tremendous unmet medical need for new therapies, panel member Philip Sager, MD, told webmd.com.
A strong majority of the panel disagreed with the FDA staff's conclusion. The panel's vote was 9-2 with one abstention. The FDA doesn't have to follow the advice of its outside panels, but usually does.
In a report earlier this week, the FDA's staff reviewer said warfarin wasn't skillfully used in the research and that may have made Xarelto look better. The report advised against approval of Xarelto for stroke prevention, a Wall Street Journal report said.
When you deal with a morbid, mortal complication like [stroke], we owe patients the best therapy we can get, says panel member Steven Nissen, MD, chair of the department of cardiovascular medicine at the Cleveland Clinic. It makes me concerned that this may be a step back, rather than a step forward, he added with a strong disagreement over the approval.
The vote has obviously come as a great news for the manufacturers of the drugs who claim Xarelto to be a potential blockbuster treatment for the heart rhythm disorder, which is getting more common among aging people.
Xarelto has already been approved in July to prevent blood clots in people having hip and knee replacement surgery.
The heart rhythm disorder known as atrial fibrillation has already affected 2.2 million Americans and is a condition that causes irregular heart beat. In this condition, a person may have blood clotting in the heart's upper chamber, which could break free, travel to the brain and cause a stroke or any other complication.