Novartis (NVS) said an advisory committee for the Food and Drug Administration has voted against the safety of its gouty arthritis drug.

The committee, which historically has had a large influence on the FDAs ultimate decision, voted in favor of the overall efficacy, but suggested the drug be used in a more narrow population of patients.

The drug, called ACZ885, or canakinumab, was tested as a treatment of gouty arthritis attacks in patients who cannot obtain adequate relief with non-steroidal anti-inflammatory drugs or colchicine.

Gout is the most common form of inflammatory arthritis in adults and is characterized by recurrent attacks in the joints, particularly the toe, foot, ankle or knee.

In two late-stage studies for the drug, patients experienced superior pain relief at 72 hours and a significant reduction in the risk of new attacks over six months, compared to patients treated with the injectable steroid, triamcinolone acetonide.

"We continue to believe in the benefits of ACZ885 for this painful and debilitating disease and will work closely with the FDA to identify the right patient population who will benefit from this therapy," said Dr. Trevor Mundel, global head of development at Novartis.

The FDA will review the recommendation in its review of the supplemental biologics license application for ACZ885. The drug, which is also being reviewed in Canada and Switzerland, is being assessed by the FDA with a priority review voucher, which expedites review time to six months from 10. A decision is expected in the third-quarter of 2011.

ACZ885 is already approved in more than 45 countries as a treatment for Cryopyrin-Associated Periodic Sydromes, which is a rare, lifelong, inflammatory disorder with debilitating symptoms.

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