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ARCALYST® (rilonacept) Meets Primary and All Secondary Endpoints in Second Phase 3 Trial for Prevention of Gout Flares in Patients Initiating Uric Acid-Lowering Therapy
Date:2/28/2011

late the production of IL-1, which causes an inflammatory response in the joints and surrounding tissues.

Rilonacept, also known as IL-1 Trap, is an agent that inhibits IL-1.  It was designed using the same proprietary Trap technology used to develop Regeneron's other product candidates, VEGF Trap and VEGF Trap-Eye.  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 ARCALYSTRilonacept, marketed as ARCALYST, 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.  The safety and efficacy of ARCALYST® (rilonacept) in the gout setting have not been evaluated by the U.S. Food and Drug Administration.  ARCALYST is not approved for use in gout.

IL-1 blockade may interfere with immune response to infections.  Serious, life-threatening infections have been reported in patients taking rilonacept.  Rilonacept should be discontinued if a patient develops a serious infection.  Taking rilonacept with tumor necrosis factor inhibitors is not recommended because this may increase the risk of serious infections.  Treatment with rilonacept should not be initiated in patients with active or chronic infections.  Patients should not receive a live vaccine while taking rilonacept.  It is recommended that patients receive all recommended vaccinations prior to initiation of treatment with rilonac
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SOURCE Regeneron Pharmaceuticals, Inc.
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