FDA Committee Backs Heart Arrhythmia Drug

Rivaroxiban gets the green light for approval from FDA committee

(RxWiki News) In a what came as a surprise move to many, the U.S. Food and Drug Administration advisory committee today voted to recommend heart arrhythmia drug rivaroxiban (Xarelto) for approval.

It was backed in a 9-2 vote with one abstention.

The medication is designed to prevent stroke in high-risk patients with atrial fibrillation, a common heart arrhythmia. Such patients are at a higher stroke risk.

"Continue with your usual arrhythmia treatment."

Often the FDA will follow recommendations such as this one by the Cardiovascular and Renal Drugs Advisory Committee, but it isn't bound to approve the medication.

A report released just days ago showed that FDA reviewers warned against the immediate approval of the drug and questioned its effectiveness following last year's large-scale ROCKET AF trial. The double blind study enrolled more than 14,000 patients.

As compared to warfarin, it reduced the rate of stroke and non-central nervous system embolism, but wasn't found to be superior at preventing blood clots.

Currently warfarin is considered the standard for preventing stroke in patients with atrial fibrillation. To gain approval, drug maker Johnson & Johnson needed to prove the proposed drug is as effective as older treatment warfarin.

Many patients have been searching for alternative treatments to the drug because it requires regular blood testing to get the doses right and can be problematic with certain foods and other medications.

Rivaroxaban already is approved in the United States as an anti-clotting agent after knee and hip surgery.

Review Date: 
September 8, 2011