FDA Approves Sarilumab for Polyarticular Juvenile Idiopathic Arthritis


The approval was based on previous data from well-controlled RA studies coupled with findings from a multinational, dose-finding study of pediatric patients with pJIA.

FDA Approves Sarilumab for pJIA

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved sarilumab (Kevzara) for patients weighing ≥ 63 kg with active polyarticular juvenile idiopathic arthritis (pJIA).1

“Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic inflammation,” said George D Yancopoulos, MD, PhD, Board co-Chair, President and Chief Scientific Officer at Regeneron.1 "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 injectable human monoclonal antibody targeting interleukin (IL)-6 receptors was first approved for the treatment of adult patients with moderate to severe, active rheumatoid arthritis (RA) who had an inadequate response or intolerance to ≥ 1 disease-modifying antirheumatic drug (DMARD) in May 2017.2

In February 2023, the drug became the only approved biologic indicated for patients with polymyalgia rheumatica—a rare inflammatory rheumatic disease that commonly presents with pain and stiffness around the hip, shoulder, and neck—who had inadequate response to corticosteroids or cannot tolerate a corticosteroid taper.3

The current approval was based on previous data from the well-controlled RA studies coupled with findings from a multinational, open-label, dose-finding study of patients aged 2 – 17 with pJIA. A total of 42 patients were divided by body weight and received sequential ascending doses of sarilumab. The primary outcome was pharmacokinetics, while secondary outcomes included the pharmacodynamics, long-term safety, and efficacy of the drug.4

At the end of the 12-week core treatment phase, the doses tested demonstrated similar exposure across weight groups and were comparable to equivalent doses in adult patients with RA. The drug was proven to decrease disease activity and the safety profile was consistent with previous data. The most common adverse events were nasopharyngitis, upper respiratory tract infection, neutropenia, and injection site erythema.4

“This latest approval for Kevzara brings a new treatment option with an established efficacy and safety profile to pediatric patients living with polyarticular juvenile idiopathic arthritis,” said Brian Foard, Executive Vice President, Head, Specialty Care at Sanofi.1 “This milestone highlights our ongoing commitment to bringing medicines to our younger patients living with this chronic condition that can cause debilitating joint pain and inflammation.”


  1. Kevzara® (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis (pjia). Regeneron Pharmaceuticals Inc. June 11, 2024. Accessed June 11, 2024. https://investor.regeneron.com/news-releases/news-release-details/kevzarar-sarilumab-approved-fda-treatment-active-polyarticular.
  2. Kgi-Admin. Sarilumab by Regeneron Pharmaceuticals for polyarticular juvenile idiopathic arthritis (PJIA): Likelihood of approval. Pharmaceutical Technology. February 22, 2024. Accessed June 4, 2024. https://www.pharmaceutical-technology.com/data-insights/sarilumab-regeneron-pharmaceuticals-polyarticular-juvenile-idiopathic-arthritis-pjia-likelihood-of-approval/#:~:text=Sarilumab%20is%20under%20development%20for,%2C%20morphea%20(localized%20scleroderma).
  3. Pine L. FDA approves sarilumab as first, only biologic treatment for polymyalgia rheumatica. HCP Live. March 1, 2023. Accessed June 4, 2024. https://www.hcplive.com/view/fda-approves-sarilumab-as-first-only-biologic-treatment-for-polymyalgia-rheumatica.
  4. Benedetti FD, Penadés IC, Pérez NER, et al. Fri0549 sarilumab, a human monoclonal antibody to the interleukin-6 (IL-6) receptor, in polyarticular-course juvenile idiopathic arthritis (PCJIA): A 12-week multinational open-label dose-finding study. Annals of the Rheumatic Diseases. June 1, 2019. Accessed June 4, 2024. https://ard.bmj.com/content/78/Suppl_2/969.2.
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