FDA Approves Regeneron's Kevzara To Treat Inflammatory Rheumatic Disease

(RTTNews) - The U.S. Food and Drug Administration approved Kevzara (sarilumab) for the treatment of polymyalgia rheumatica, an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper, Regeneron Pharmaceuticals Inc. (REGN) and Sanofi said in a statement on Tuesday.

Kevzara is now approved to treat two chronic inflammatory disorders.

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.

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. Polymyalgia rheumatica generally affects people who are 50 years and older.

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.

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