FDA Advisory Committee rejects Arcalyst(Regeneron) for treatment of Gout Flares

The FDA Arthritis Advisory Committee rejected Arcalyst (rilonacept) from Regeneron , voting 11-0 that the data submitted had failed to support the approval of a subcutaneous once weekly dosage of Arcalyst to prevent Gout Flares. The Advisory Committee noted the small numbers of patients in the studies and the absence of long term and safety data which did not exist beyond 16 weeks. Some members of the Committee felt that the effect in the studies was "modest" and noted that there was no comparison with NSAIDs or Colchicine treatment.Gout patients enrolled in the Arcalyst trials were not the chronic refractory patients for which other measures has proven ineffective.