FDA Approves Sanofi/Regeneron's Kevzara for Polyarticular Juvenile Idiopathic Arthritis

Sanofi and Regeneron have received approval from the US Food and Drug Administration (FDA) for their drug Kevzara (sarilumab) to treat active polyarticular juvenile idiopathic arthritis (pJIA) in patients who weigh at least 63 kilograms. pJIA is identified as one of the three major forms of juvenile idiopathic arthritis, a chronic condition that affects multiple joints simultaneously. This ailment results in symptoms such as joint pain, stiffness, and swelling, potentially leading to permanent joint damage and delayed growth and development.

In patients with rheumatoid arthritis, the immune system protein IL-6 is produced in higher quantities. This protein has been linked to disease activity, joint destruction, and other systemic issues. Kevzara, a product of a global collaboration between Sanofi and Regeneron, specifically targets the IL-6 receptor and has been demonstrated to inhibit IL-6-mediated signaling. Prior to this new approval, Kevzara was already sanctioned in the US for treating adults with polymyalgia rheumatica and moderately to severely active rheumatoid arthritis.

The FDA based its recent decision on robust evidence from well-controlled studies and pharmacokinetic data from adult patients with rheumatoid arthritis, along with a pharmacokinetic, pharmacodynamic, dose-finding, and safety study in pediatric patients with pJIA. Importantly, no new adverse reactions or safety issues were identified in the pJIA patient group compared to the rheumatoid arthritis population.

Brian Foard, Executive Vice President and Head of Specialty Care at Sanofi, highlighted that the latest approval offers a new treatment option with a well-established efficacy and safety profile for pediatric patients suffering from pJIA. George Yancopoulos, Board Co-Chair, President, and Chief Scientific Officer at Regeneron, also remarked that without adequate treatment, the daily lives and futures of pJIA patients could be significantly impacted. He emphasized that the FDA's approval of Kevzara provides a new treatment option for these vulnerable patients and their families.

This new approval for Kevzara follows a recent recommendation by the European Medicines Agency’s human medicines committee for another drug from Sanofi and Regeneron, Dupixent (dupilumab). Dupixent was recommended as an add-on maintenance treatment for certain patients with chronic obstructive pulmonary disease (COPD). Should the European Commission approve it, Dupixent would become the first targeted therapy for COPD in the European Union and represent the first new treatment approach for the disease in over ten years.