FDA Requests More Data of Novartis Gout Drug
The FDA requested additional information surrounding canakinumab including clinical data to evaluate the benefit-risk profile in refractory patients.
The US FDA has rejected canakinumab 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. Novatis will continue to
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