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Kevzara® (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica
Three times more patients treated with Kevzara achieved sustained remission compared to placebo in Phase 3 trial Kevzara now approved to treat two chronic
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Three times more patients treated with Kevzara achieved sustained remission compared to placebo in Phase 3 trial Kevzara now approved to treat two chronic inflammatory disorders TARRYTOWN, N.Y. and CAMBRIDGE, Mass., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. \"Polymyalgia rheumatica can be an incapacitating disease, causing painful disease flares in multiple parts of the body that leave people fatigued and unable to fully perform everyday activities. Corticosteroids have been the primary treatment to date, but many patients do not adequately respond to steroids or cannot be tapered off steroids, which puts such patients at risk of complications from long-term steroid therapy,” said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron. “With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependance on steroids.” The FDA evaluated the Kevzara application for PMR under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Kevzara was previously approved for the treatment of moderately-to-severely active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs. PMR often initially presents with pain and stiffness around the neck, shoulder and hip area and symptoms include fatigue, low-grade fever and weight loss. Patients often experience flares during tapering of, or relapse after discontinuation of corticosteroid (CS) treatment. Patients with PMR report difficulty in carrying out everyday functions such as getting out of bed, standing up from a chair, or lifting their arms. PMR generally affects people who are 50 years and older. “Until now, people living with polymyalgia rheumatica have had limited treatment options for...