FDA Approves Kevzara® for Treating Active Polyarticular Juvenile Idiopathic Arthritis

Regeneron Pharmaceuticals, Inc. and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has approved the use of Kevzara (sarilumab) for treating patients weighing 63 kg or more with active polyarticular juvenile idiopathic arthritis (pJIA). This form of arthritis affects multiple joints and can cause significant pain and inflammation in children, potentially impacting their daily lives and future development without proper treatment.

George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer at Regeneron, highlighted the importance of this approval, emphasizing the need for effective treatment options for children suffering from pJIA. The FDA's decision is based on comprehensive studies and pharmacokinetic data from both adult rheumatoid arthritis patients and pediatric patients with pJIA. These studies confirmed the efficacy and safety of Kevzara in this young patient population.

pJIA is characterized by symptoms such as pain, stiffness, and swelling of the joints, which can severely restrict a patient's activities and daily functioning. If not properly managed, the disease can lead to permanent joint damage and hinder a child's growth and development due to chronic inflammation. The approval of Kevzara offers a new glimmer of hope for these patients and their families.

In clinical trials, no new adverse reactions were observed in the pJIA population compared to those with rheumatoid arthritis. Common adverse reactions included nasopharyngitis, neutropenia, upper respiratory tract infections, and injection site erythema. Neutropenia was the most common reason for discontinuing Kevzara therapy. Patients treated with Kevzara are at an increased risk of developing serious infections, which could lead to hospitalization or death.

Brian Foard, Executive Vice President and Head of Specialty Care at Sanofi, noted that this approval provides a new, reliable treatment option for pediatric patients suffering from pJIA. He emphasized the company's ongoing commitment to delivering effective medications for younger patients dealing with chronic conditions that cause severe joint pain and inflammation.

Sanofi and Regeneron are dedicated to assisting patients in the U.S. who are prescribed Kevzara. They offer comprehensive support services through KevzaraConnect, a program that helps patients who are uninsured, lack coverage, or need copay assistance. This initiative aims to ensure that eligible patients receive the necessary support throughout their treatment process.

Kevzara is also approved in 25 countries for treating adults with moderately to severely active rheumatoid arthritis, especially when other disease-modifying antirheumatic drugs (DMARDs) have failed or were not tolerated. Additionally, Kevzara is authorized for treating polymyalgia rheumatica in adult patients in the U.S. who have not responded adequately to corticosteroids or cannot tolerate them.

Sarilumab, the active ingredient in Kevzara, works by binding specifically to the IL-6 receptor, inhibiting IL-6-mediated signaling. IL-6 is an immune system protein that is produced in increased quantities in patients with rheumatoid arthritis and is associated with disease activity and joint destruction.

Regeneron utilizes its proprietary VelocImmune technology, which involves a genetically engineered mouse platform with a humanized immune system to produce fully human antibodies. This technology has led to the creation of several FDA-approved or authorized antibodies, including Kevzara.

Regeneron is a leading biotechnology company dedicated to developing and commercializing transformative medicines. Their innovative approach has resulted in numerous FDA-approved treatments and a robust pipeline of product candidates aimed at addressing serious diseases. Through their proprietary technologies and research initiatives, Regeneron is continuously working to accelerate and enhance the drug development process.

Sanofi, a global healthcare company, is driven by the mission to improve lives through scientific advancements. They provide life-changing treatment options and vaccines to millions worldwide, with a strong focus on sustainability and social responsibility.