Arthritis Advisory Committee Unanimously Against Arcalyst for Gout

The Arthritis Advisory Committee voted 11-0 against recommending FDA approval of Arcalyst (rilonacept) for the prevention of gout flares in patients starting urate-lowering treatment. Arcalyst, a drug being developed by Regeneron, is an interleukin-1 blocker. The advisory panel did not feel that benefits outweighed risks in data presented for Arcalyst. They also felt that 16 weeks, the duration of trials, was inadequate.

The committee voted 6-5 that Arcalyst is effective for treating gout flares. They also voted 8-3 that Regeneron's safety data was insufficient. The committee felt the study was too short to assess cancer risk. Regeneron studied Arcalyst on patients who were capable of taking other gout medications. It was suggested that, if patients who could not take other treatments were studied, more useful data may be produced.

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