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

le for the Clinical Exploration of Use of ARCALYST® (rilonacept) in the Prevention of Gout Flares in Patients Initiating Uric Acid-lowering TherapyInterleukin-1 (IL-1) is a protein secreted by infection-fighting cells in the blood and tissues.  In many cases, IL-1 acts as a messenger to help regulate immune and inflammatory responses by attaching to cell-surface receptors in cells that participate in the body's immune system.  In excess, it can be harmful and has been shown to be a key driver of inflammation in a variety of diseases.  In patients with gout who are initiating uric acid-lowering therapy, redistributed uric acid crystals stimulate the production of IL-1, which triggers an inflammatory response in the joints and surrounding tissues, resulting in acute gout flares

Rilonacept, known in the scientific literature as IL-1 Trap, is an agent that inhibits IL-1.  It was designed using Regeneron's proprietary Trap technology.  Specifically, rilonacept is designed to attach to and neutralize IL-1 in the blood stream before the IL-1 can attach to cell-surface receptors and generate signals that can trigger disease activity in body tissue.  Once attached to rilonacept, IL-1 cannot bind to the cell-surface receptors and is eventually eliminated from the body.

Important information about ARCALYSTARCALYST, is currently indicated in the U.S. for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.  Rilonacept is also approved, but not marketed, in the E.U. for the same patient population.  ARCALYST is not approved, but is currently under review by the U.S. FDA, for the prevention of gout flares in patients initiating uric acid-lowering therapy.

IL-1 blockade may interfere with immune response to infections.  Serious, life-threatening infections have been repor
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SOURCE Regeneron Pharmaceuticals, Inc.
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