According to a report by Medpage Today, an FDA advisory panel has ruled that the monoclonal antibody canakinumab (Ilaris®) is ‘too risky’ to warrant its approval for the treatment of gouty arthritis.

The FDA's Arthritis Advisory Committee largely agreed (11-1 vote) that the efficacy data for the biological drug in the treatment of gouty arthritis were adequate in terms of symptomatic relief, but they unanimously voted that its safety is inadequate for approval.  The panel was more divided on the question of whether the drug reduced frequency of subsequent attacks; with members voting 8-4 that the efficacy data supported such a claim.

The panel concluded overall that 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).

In a briefing document prepared for the committee meeting, FDA staff had raised concerns about increased rates of infections, high triglyceride levels, and elevated uric acid levels in blood seen in clinical trials of canakinumab for gout and rheumatoid arthritis.

[Editor’s note: Canakinumab is a monoclonal antibody targeting the interleukin-1-beta protein, currently licensed in the UK for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in adults, adolescents and children aged 4 years and older.]