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FDA rejects Novartis gout medication
- Publisher：
- Publication：2011/8/31
The US Food and Drug Administration (FDA) has rejected canakinumab, a drug developed by Novatis to treat gout.
The decision follows an 11-1 vote against approving the drug to treat gouty arthritis attacks by the agency's Arthritis Advisory Committee in June this year.
In a complete response letter, the FDA requested additional information surrounding the drug including clinical data to evaluate the benefit-risk profile in refractory patients.
Novartis has noted that the FDA panel voted in favour of the overall efficacy of canakinumab, and that the response letter confirms that the agency is querying the drug's overall safety profile.
The company has confirmed it will continue to work with the FDA on approving canakinumab. Tthe drug is already approved in Europe and the US for the treatment of cryopyrin-associated periodic syndrome.