FDA Advisors Reject Novartis Gout Drug

The FDA’s Arthritis Advisory Committee firmly voted against recommending the Novartis drug, Ilaris, as a treatment for gout. The 11 to 1 vote against backing the drug stemmed from safety concerns over the risk for patients to develop serious infections and other problems.

While the panel noted that the data did demonstrate the drug is effective as a treatment of gout, it is still linked to a higher rate of serious infections after only a single injection. The panel also suggested that review of the current data did raise hopes that additional data and a specific set of marketing restrictions could ultimately pave the way to FDA approval.

The drug’s maker, Novartis, had predicted that if the FDA’s advisory panel would have approved ilaris for use as a treatment for gout and juvenile rheumatoid arthritis, the medicine could have generated blockbuster sales for the company.

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