FDA Advisory Committee voted against approval of ARCALYST for the prevention of gout flares during initiation of uric acid-lowering therapy
TARRYTOWN, NY, USA I May 8, 2012 I Regeneron Pharmaceuticals, Inc. (REGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) voted against approval of ARCALYST® (rilonacept) Injection for Subcutaneous Use for the proposed indication for the prevention of gout flares in patients initiating uric acid-lowering therapy. The Committee’s recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) for ARCALYST, but the Committee’s recommendation is not binding on the FDA. Regeneron submitted an sBLA for marketing approval of ARCALYST in the United States and has been granted a target date for an FDA decision of July 30, 2012.
Important information about ARCALYST® (rilonacept) Injection
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. 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 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 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 Pharmaceuticals
Regeneron 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 in the United States, ARCALYST® (rilonacept) Injection for Subcutaneous Use and EYLEA® (aflibercept) Injection, and has filed regulatory applications with the U.S. Food and Drug Administration (FDA) for second indications for each of these products. A regulatory application has also been submitted to the FDA for the product candidate ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion. Phase 3 studies are in progress with EYLEA® in a third indication, and with product candidate sarilumab. Earlier-stage clinical programs are underway with nine additional monoclonal antibodies. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional information and recent news releases are available on the Regeneron web site at www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals
Post Views: 28
FDA Advisory Committee voted against approval of ARCALYST for the prevention of gout flares during initiation of uric acid-lowering therapy
TARRYTOWN, NY, USA I May 8, 2012 I Regeneron Pharmaceuticals, Inc. (REGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) voted against approval of ARCALYST® (rilonacept) Injection for Subcutaneous Use for the proposed indication for the prevention of gout flares in patients initiating uric acid-lowering therapy. The Committee’s recommendation will be considered by the FDA in its review of the supplemental Biologics License Application (sBLA) for ARCALYST, but the Committee’s recommendation is not binding on the FDA. Regeneron submitted an sBLA for marketing approval of ARCALYST in the United States and has been granted a target date for an FDA decision of July 30, 2012.
Important information about ARCALYST® (rilonacept) Injection
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. 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 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 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 Pharmaceuticals
Regeneron 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 in the United States, ARCALYST® (rilonacept) Injection for Subcutaneous Use and EYLEA® (aflibercept) Injection, and has filed regulatory applications with the U.S. Food and Drug Administration (FDA) for second indications for each of these products. A regulatory application has also been submitted to the FDA for the product candidate ZALTRAP® (aflibercept) Concentrate for Intravenous Infusion. Phase 3 studies are in progress with EYLEA® in a third indication, and with product candidate sarilumab. Earlier-stage clinical programs are underway with nine additional monoclonal antibodies. Regeneron has active research and development programs in many disease areas, including ophthalmology, inflammation, cancer, and hypercholesterolemia. Additional information and recent news releases are available on the Regeneron web site at www.regeneron.com.
SOURCE: Regeneron Pharmaceuticals
Post Views: 28
