An FDA panel made up of outside experts convened today in order to decide whether or not to recommend approval of the Novartis product, Ilaris, for use in the treatment of gout. Ultimately, the committee of advisors voted 11 to 1 against recommending approval of the drug as a treatment for gout attacks, as well as voting unanimously against use of the drug for delaying and reducing the frequency of gout attacks.
At present, the drug is being sold to treat a rare inflammatory disorder. Novartis had predicted that if the FDA’s advisory panel would have cleared Ilaris for use as a treatment for gout and juvenile rheumatoid arthritis, the medicine could have generated blockbuster sales for the company.
Most of the panel’s advisors concluded that while the drug was effective in the treatment of gout, it was also linked to higher rates of serious infections and other potential side effects that raised concern. The subsequent rejection by the panel makes U.S. approval for the Novartis gout treatment unlikely without additional data.
Gout is a type of arthritis that occurs when uric acid builds up in the joints, and according to Novartis, approximately 8.3 million adults in the United States have the condition.