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

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 at a weekly, self-administered, subcutaneous dose of 160mg had a 72% decrease in mean number of gout flares (p<0.0001) and patients who received the 80mg dose had a 72% decrease compared to the placebo group (p<0.0001).

Overall in PRE-SURGE 2, the cumulative rate of infections was 27.4% in patients treated with ARCALYST 160mg, 28.0% in patients treated with ARCALYST 80mg, and 25.6% in placebo patients.  No deaths were reported in this study.

In both trials, a gout flare was defined as patient-reported acute articular pain typical of a gout attack that was deemed (by the patient and/or the investigator) to require treatment with an anti-inflammatory therapeutic and involved at least three of four signs/symptoms (joint swelling, redness, tenderness, and pain) and one or more of the following: rapid onset of pain, decreased range of motion, joint warmth, or other symptoms similar to a prior gout flare.

The global RE-SURGE (REview of Safety Using Rilonacept in preventing Gout Exacerbations) study was a double-blind, placebo-controlled study primarily focused on evaluation of safety.  A total of 1315 patients who were at risk for gout flares because they were initiating or taking uric acid-lowering drug treatment were randomly assigned in a 1:3 ratio to receive either weekly placebo injections for 16 weeks or weekly subcutaneous injections of ARCALYST dosed at 320mg as an initial loading dose and 160mg thereafter for a total of 16 weeks.  In this trial, a gout flare was defined as patient-reported acute articular pain typical of a gout attack that was deemed (by the patient and/or the investigator) to require treatment with an anti-
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SOURCE Regeneron Pharmaceuticals, Inc.
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