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Regeneron Announces FDA Acceptance of ARCALYST® (rilonacept) Supplemental Biologics License Application for Review
Date:11/22/2011

the incidence of serious adverse events generally well-balanced across the placebo and ARCALYST groups.  Injection site reactions, usually considered mild, were reported more commonly with ARCALYST than with placebo.  A third study, RE-SURGE, evaluated the safety of ARCALYST in patients who were at risk for gout flares because they were initiating or taking uric acid-lowering drug treatment.  This study showed that ARCALYST was generally well tolerated and the safety profile was consistent with that reported in the PRE-SURGE 1 and PRE-SURGE 2 studies.

About the Phase 3 ARCALYST Program in GoutIn the PRE-SURGE 1 and PRE-SURGE 2 studies, 488 patients were randomized to receive one of the following treatment regimens: ARCALYST 160 milligrams (mg) as an initial subcutaneous loading dose followed by weekly 80mg subcutaneous injections for 16 weeks, or ARCALYST 320mg as an initial subcutaneous loading dose followed by weekly 160mg subcutaneous injections for a total of 16 weeks, or subcutaneous weekly placebo injections for 16 weeks.

The North American PRE-SURGE 1 (PREventative Study against URate lowering drug-induced Gout Exacerbations) study was a double-blind, placebo-controlled study which evaluated the number of gout flares per patient over the first 16 weeks following initiation of allopurinol therapy.  Patients who received ARCALYST (rilonacept) at a weekly, self-administered, subcutaneous dose of 160mg had an 80% decrease in mean number of gout flares (p<0.0001) and patients receiving the 80mg dose had a 73% decrease compared to the placebo group (p<0.0001).

Overall in PRE-SURGE 1, the cumulative rate of infections was 17.3% in patients treated with ARCALYST 160mg, 18.8% in patients treated with ARCALYST 80mg, and 22.8% in placebo patients.  No deaths were reported in this study.

The global PRE-SURGE 2 (PREventative Study against URate-lowering
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SOURCE Regeneron Pharmaceuticals, Inc.
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