FDA demands more data on Novartis's ACZ885

Novartis's ($NVS) plans to expand the use of ACZ885 in a drive to achieve blockbuster status ran into a roadblock this morning. The pharma giant says that the FDA handed the company a complete response letter detailing its demands for more data on gouty arthritis patients ahead of any final decision on the treatment. The FDA wants more data on the clinical risk/benefit in refractory patients. An expert panel voted in favor of the drug's efficacy back in June but noted the need for more safety data. Report

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