According to a report by PharmaLive, the US Food and Drug Administration (FDA) has issued a “Complete Response Letter” to Novartis requesting additional information, including clinical data to evaluate the benefit-risk profile for the use of canakinumab for gout.

According to the report, an advisory committee of the FDA had voted in favour of the overall efficacy of canakinumab, but recommended that additional retreatment data would be needed to assess the overall safety profile of the drug.

Separately, an FDA panel had previously concluded that overall, the efficacy and safety data together did not justify approval of canakinumab as a treatment for acute gouty arthritis (11-1) or to increase time between future attacks (12-0) – please see link to NeLM report below.