Sanofi, Regeneron Pharma bag USFDA nod for Kevzara to treat polymyalgia rheumatica
Polymyalgia rheumatica often initially presents with pain and stiffness around the neck, shoulder and hip area and symptoms include fatigue, low-grade fever and weight loss.;
Tarrytown: Sanofi and Regeneron Pharmaceuticals have 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.
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