The approval was based on findings from the SAPHYR phase 3 clinical trial in which 28% of patients treated with Kevzara achieved sustained remission compared to 10% for placebo
Kevzara 200mg syringe. (Credit: MultiVu, a Cision company/ Sanofi/Regeneron Pharmaceuticals, Inc.)
Regeneron Pharmaceuticals and Sanofi have received approval from the US Food and Drug Administration (FDA) for their jointly developed Kevzara (sarilumab) to treat polymyalgia rheumatica (PMR) in adult patients.
With this approval, Kevzara is the first and only biologic indicated for polymyalgia rheumatica patients who did not respond to corticosteroids or who cannot tolerate corticosteroid (CS) taper.
Developed by using Regeneron’s proprietary VelocImmune technology, Kevzara is an injectable prescription medicine designed to block the interleukin-6 (IL-6) receptor. It specifically binds to the receptor and has been shown to inhibit IL-6-mediated signalling.
The FDA approval was based on the findings from the randomised SAPHYR phase 3 clinical trial, which recruited steroid-resistant active polymyalgia rheumatica patients.
Regeneron said that the patients were randomised to receive either Kevzara 200mg every two weeks along with a 14-week taper of CS or placebo every two weeks along with a 52-week CS taper.
The study met its primary endpoint, with 28% of patients treated with Kevzara achieving sustained remission compared to 10% for placebo at the end of 52 weeks.
Regeneron president and chief scientific officer George Yancopoulos said: “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.
“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.”
Previously, Kevzara was approved in several countries to treat moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have not responded to one or more disease-modifying antirheumatic drugs.
Regeneron and France-based Sanofi jointly develop the IL-6 inhibitor under a global collaboration agreement.