FDA staff question studies for Regeneron gout drug

Staff walk among the new buildings at the the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland, November 5, 2009.

Credit: Reuters/Jason Reed

WASHINGTON | Fri May 4, 2012 1:52pm BST

WASHINGTON (Reuters) - U.S. drug reviewers said Regeneron Pharmaceuticals Inc's drug to prevent gout flares worked, but questioned its side effects and whether it did enough to help patients.

The Food and Drug Administration staff on Friday said the injectable drug, called Arcalyst, was meant to be used for only 16 weeks to prevent gout flares - the first treatment for the condition with such a limited timeline.

The FDA staff review comes ahead of an advisory panel of outside experts, which will vote on whether to recommend the drug next Tuesday. The FDA will make a final decision by July 30, taking into account the panel's recommendations.

Regeneron's drug, known generically as rilonacept, is already approved to treat a group of rare genetic auto-inflammatory diseases. But the company is hoping to expand its use to prevent gout flares in people starting uric acid-lowering therapy.

Gout is a painful condition that occurs when the bodily waste product, uric acid, is deposited in the joints and soft tissues. It affects about 5 million to 6 million Americans.

While there are already treatments for gout flares in general, none exist specifically for people who are starting therapy to lower their uric acid, and none is meant to be used for only 16 weeks, the FDA staff said.

"From an efficacy standpoint, it will be important to address whether 16 weeks provide for an adequate duration for flare prophylaxis during initiation of (uric acid-lowering therapy," the staff said, according to documents posted online on Friday.

Continued here:
FDA staff question studies for Regeneron gout drug