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US FDA Panel: Regeneron's Arcalyst not ready for gout

 
• By Donna Young

Worried that doctors eager for new gout treatments would prescribe Regeneron's Arcalyst (rilonacept) for high-risk patients with aggressive or refractory disease, populations for which there is a lack of data, the US FDA's Arthritis Advisory Committee on 8 May refused to back the drug as a treatment for the condition.

Worried that doctors eager for new gout treatments would prescribe Regeneron's Arcalyst (rilonacept) for high-risk patients with aggressive or refractory disease, populations for which there is a lack of data, the US FDA's Arthritis Advisory Committee on 8 May refused to back the drug as a treatment for the condition.

The committee voted 11-0 that Regeneron's efficacy and safety data failed to support the approval of a subcutaneous once-weekly 80mg...

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