Pharma Focus Asia

Regeneron and Sanofi Announce U.S. FDA Approval of Kevzara® (sarilumab)

Tuesday, February 28, 2023

Regeneron Pharmaceuticals and Sanofi 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 consisting of inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

Kevzara is approved in multiple countries to treat adults with moderately to severely active rheumatoid arthritis who have not responded to or tolerated previous therapy.

Until now, people living with polymyalgia rheumatica have limited treatment options for this serious rheumatic condition, which causes significant pain and discomfort. The approval of Kevzara as the first and only biologic for polymyalgia rheumatica is a new option for patients and the healthcare professionals.

Polymyalgia rheumatica is 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 is considered to be the first-line therapy until now, 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. 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.

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