US FDA stalls Novartis Ilaris approval for gouty arthritis, calling for more clinical data

31 August 2011

There was a big disappointment, albeit not unexpected, for Swiss drug major Novartis (NOVN: VX) when the US Food and Drug Administration issued a complete response letter regarding the company’s Ilaris (canakinumab; ACZ885) for the treatment of gouty arthritis. Currently there are no targeted biologics for gouty arthritis except for non-steroidal anti-inflammatory drugs (NSAIDs) or colchicine.

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