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

ted 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 rilonacept.  Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted.  Hypersensitivity reactions associated with rilonacept administration have been rare.  Please see the full Prescribing Information for ARCALYST® (rilonacept), available online at www.regeneron.com/ARCALYST-fpi.pdf.

About Regeneron PharmaceuticalsRegeneron is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.  Regeneron markets two products, ARCALYST® (rilonacept) Injection For Subcutaneous Use and EYLEA™ (aflibercept) Injection.  Regeneron also has completed several Phase 3 studies and is conducting an additional Phase 3 clinical trial for the product candidate ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion.  Additional therapeutic candidates developed from proprietary Regeneron technologies for creating fully human monoclonal antibodies are in earlier stage development programs in rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer.  Additional information about Regeneron and recent news releases are available on the Regeneron web site at

SOURCE Regeneron Pharmaceuticals, Inc.
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