FDA experts reject Novartis gout drug

A solid majority of the experts sitting on an FDA advisory committee has turned thumbs down on Novartis's application for the gout therapy Ilaris, citing safety concerns. But the 11-1 rejection doesn't mean that Novartis is completely out of luck. The panel also noted that the data demonstrates the drug is effective and raised hopes that more data or a specific set of marketing restrictions could yet pave the way to an approval. The panel vote, of course, isn't a formal rejection. But the FDA has proven time and again that it is keeping a critical eye on anything to do with safety concerns. In this case, Ilaris has been linked with a higher rate of serious infections after a single injection. The drug gained an approval two years ago for a rare condition. Report

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