Arthritis Advisory Committee Meeting
Committee Meeting May 8th from 8:00 a.m. to 5:00 p.m.
Agenda: On May 8, 2012, the committee will discuss supplemental biologics license application 125249, ARCALYST (rilonacept) injection, Regeneron Pharmaceuticals, Inc., for the following proposed indication: "ARCALYST (rilonacept) is an interleukin-1 blocker indicated for the prevention of gout flares during initiation of uric-acid lowering therapy in adult patients with gout. ARCALYST has not been studied for longer than 16 weeks in this clinical setting.
Wednesday, March 14, 2012
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