Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis – Regeneron + Sanofi

Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has approved Kevzara (sarilumab) for the treatment of patients weighing 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA), a form of arthritis that impacts multiple joints at a time.

“Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D. Yancopoulos, M.D., Ph.D., Board co-Chair, President and Chief Scientific Officer at Regeneron. “Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment. The approval of Kevzara in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.”

The FDA approval in this patient population is supported by evidence from adequate and well-controlled studies and pharmacokinetic data from adults with rheumatoid arthritis as well as a pharmacokinetic, pharmacodynamic, dose finding and safety study in pediatric patients with pJIA. People living with pJIA may experience joint symptoms such as pain, stiffness and swelling, which may restrict their activities and make certain aspects of their day-to-day life incredibly challenging. The disease can lead to an increased risk of permanent joint damage as well as delayed growth and development, due to chronic joint inflammation.

No new adverse reactions (ARs) and safety concerns were identified in the pJIA population compared to the rheumatoid arthritis population. The most common adverse drug reactions for patients with pJIA were nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema. The most common AR that resulted in permanent discontinuation of therapy with Kevzara was neutropenia. Overall, patients treated with Kevzara are at increased risk for developing serious infections that may lead to hospitalization or death.

Sanofi and Regeneron are committed to helping patients in the U.S. who are prescribed Kevzara gain access to the medicine and receive the support they may need. KevzaraConnect, a comprehensive and specialized program that provides support services to patients throughout every step of the treatment process, can help eligible patients who are uninsured, lack coverage, or need copay assistance. For more information, please call: 1-844-Kevzara (1-844-538-9272) or visit www.Kevzara.com.