FDA OKs Kevzara
The Food and Drug Administration has approved Kevzara (sarilumab), a product jointly developed by Sanofi and Regeneron, 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.
“Until now, people living with polymyalgia rheumatica have had limited treatment options for this serious rheumatic condition which causes significant pain and discomfort," said Bill Sibold, executive vice president and head of specialty care at Sanofi. "The approval of Kevzara as the first and only biologic for polymyalgia rheumatica is a new option for patients and the healthcare professionals who treat them.”
PMR often initially presents with pain and stiffness around the neck, shoulder and hip area. Symptoms include fatigue, low-grade fever and weight loss. Patients often experience flares during tapering or relapse after discontinuing corticosteroid treatment. Patients with PMR report difficulty 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.
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"Polymyalgia rheumatica can be an incapacitating disease, causing painful disease flares in multiple parts of the bodies that leave people fatigued and unable to fully perform everyday activities," said George Yancopolous, president and chief scientific officer at Regeneron. "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. 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 dependence on steroids.”
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