FDA Refuses to Approve Savient Gout Drug

EAST BRUNSWICK, N.J. (TheStreet) -- Manufacturing problems have delayed the approval and launch of Savient Pharmaceuticals'(SVNT Quote) gout drug until 2010.

The U.S. Food and Drug Administration refused to approve the Savient drug, known as Krystexxa, because the agency was not satisfied that commercial supplies of the drug were the same as the drug used during clinical trials.

Savient announced the FDA decision Sunday night, which came in the form of a complete response letter. The company said it intends to submit a response to the FDA's concerns in early 2010.

Gout is a disease in which uric acid builds up in the bloodstream and collects in the joints, where it can cause painful swelling and stiffness. Savient is seeking FDA approval for Krystexxa as a treatment for patients with gout who fail to respond to earlier therapy.

An advisory committee to the FDA convened on June 17 recommended Krystexxa's approval.

In its statement Sunday, Savient said it made a change to the way Krystexxa was manufactured to prepare for the commercial launch of the drug. The company submitted data to the FDA intended to show that the new Krystexxa was the same as the drug used for the clinical trials. The FDA found the comparability data "not adequate," the company said.

Savient says it intends to revert to its old manufacturing process for Krystexxa.

The FDA also asked the company to submit a risk management plan that will be used to warn doctors and patients about the risk of severe allergic reactions that can occur when Krystexxa is administered.