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

inflammatory therapeutic.

Overall, in RE-SURGE, the cumulative rate of infections was 20.1% in patients treated with ARCALYST and 19.1% in placebo patients.  Serious infections were reported in 0.5% of patients treated with ARCALYST® and 0.9% of placebo patients.  Deaths were reported for 0.3% of patients treated with ARCALYST and 0.9% of placebo patients.  The mean number of gout flares during the 16week treatment period was significantly lower in the ARCALYST 160mg treatment group when compared to placebo (0.51 and 1.73, respectively, a 71% reduction, p<0.0001). The proportion of patients with at least one gout flare was significantly lower in the ARCALYST 160mg group when compared to placebo at week 16 (25.7% [245/952] vs. 51.1% [165/323, p<0.0001].

About GoutGout is a condition that occurs when the bodily waste product, uric acid, is deposited in the joints and/or soft tissues.  In the joints, these uric acid crystals cause inflammation, which leads to pain, swelling, redness, warmth, and stiffness in the joints.  Treatment guidelines recommend that patients with elevated uric acid levels who experience multiple gout attacks each year should receive chronic uric acid-lowering therapy, such as allopurinol.  Untreated chronic gout can lead to joint and kidney damage.  Uric acid-lowering therapy can prevent the occurrence of gout attacks with long-term use and reduce the risk of organ damage.  Approximately 750,000 gout patients initiate allopurinol therapy each year.  During the first months of allopurinol therapy while uric acid blood levels are being reduced, the break up of the uric acid crystals can result in stimulation of inflammatory mediators, including interleukin-1 (IL-1), resulting in acute flares of joint pain and inflammation.  These acute flares can result in patient non-adherence to long-term uric acid-lowering therapy and resultant poor disease control.

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SOURCE Regeneron Pharmaceuticals, Inc.
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