Sarilumab FDA Approved for Active Polyarticular Juvenile Idiopathic Arthritis

The FDA has approved sarilumab (Kevzara) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing 63 kg or greater, manufacturer Regeneron announced in a news release. The approval brings a new treatment option to pediatric patients with pJIA, which is a form of arthritis affecting multiple joints.

The new approval brings a new treatment option to pediatric patients with pJIA. | Image credit: wladimir1804

“Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic infammation,” George D. Yancopoulos, MD, PhD, board cochair, president, and chief scientific officer at Regeneron, said in a statement. "Not only are their daily lives impacted, but their futures can be disrupted without adequate treatment. The approval of [sarilumab] in polyarticular juvenile idiopathic arthritis provides these vulnerable patients and their families a new FDA-approved treatment option to help navigate this disease.”

The approval was supported by data from adequate, well-controlled studies in addition to pharmacokinetic data from adults with rheumatoid arthritis and a pharmacokinetic, pharmacodynamic, dose finding, and safety study conducted in pediatric patients with pJIA, according to the release.

Those with pJIA can be affected by joint pain, stiffness, and swelling, potentially restricting their activity and making daily life more difficult. Additionally, the chronic inflammation associated with pJIA increases the risk of permanent joint damage, delayed growth, and delayed development.

There were no new adverse reactions or safety concerns in the pJIA population vs the rheumatoid arthritis population, and the most common adverse drug reactions were nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema among those with pJIA. Neutropenia was the most common adverse reaction leading to permanent discontinuation of sarilumab.

Reference

Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA). News release. Regeneron. June 11, 2024. Accessed June 11, 2024. https://investor.regeneron.com/news-releases/news-release-details/kevzarar-sarilumab-approved-fda-treatment-active-polyarticular