Tuesday, July 16, 2024

Polyarticular Juvenile Idiopathic Arthritis: FDA Approves Regeneron and Sanofi’s Kevzara for Treatment

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Polyarticular juvenile idiopathic arthritis (pJIA) treatment has advanced with the Food and Drug Administration’s (FDA) approval of Kevzara (sarilumab), developed by Regeneron and Sanofi, for patients weighing over 138 pounds. This approval was based on results from controlled studies and pharmacokinetic data from adults with rheumatoid arthritis (RA), as well as pediatric-specific studies on pharmacokinetics, pharmacodynamics, dosing, and safety.

Polyarticular juvenile idiopathic arthritis is a painful condition in children, characterized by chronic inflammation affecting multiple joints. “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. “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.”

Polyarticular Juvenile Idiopathic Arthritis: FDA Expands Kevzara Approval Beyond RA and Polymyalgia Rheumatica

Kevzara, a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), was first approved by the FDA in 2017 for adults with moderately to severely active RA who have not responded adequately or are intolerant to disease-modifying antirheumatic drugs (DMARDs) such as methotrexate. It is also indicated for adults with polymyalgia rheumatica who have not responded adequately to corticosteroids or who cannot tolerate corticosteroid tapering. IL-6 is an immune system protein that is produced in increased quantities in patients with RA and is associated with disease activity, joint destruction, and other systemic issues.

In the latest approval for Kevzara, no new adverse events (AEs) were observed in patients with pJIA compared to those with RA. Common AEs included nasopharyngitis, neutropenia, upper respiratory tract infections, and injection site erythema, with serious infections cited as a major risk. Currently, Kevzara is approved in 25 countries for the treatment of moderately to severely active RA after at least one other treatment, and is also approved in the United States for the treatment of polymyalgia rheumatica.

Polyarticular Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis: Onset, Prevalence, and Gender Disparities According to National Library of Medicine Study

According to a study published in the National Library of Medicine, pJIA can begin at any time before the age of 16 but rarely occurs before the first year of life. In the case of rheumatoid factor (RF)-negative pJIA, a patient may experience onset between the ages of 1-3 years, with a second peak between the ages of 9-14 years. pJIA is more common in girls, with a diagnosis rate two to four times higher than that of boys. On the other hand, RF-positive JIA appears to be more common in older children, typically manifesting between the ages of 10-13 years, and is also more common in girls.

Current treatments for pJIA include nonsteroidal anti-inflammatory drugs, glucocorticoids, systemic glucocorticoids, leflunomide, and various other DMARDs. Several biologics are also used in treating pJIA.

“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, EVP, head of specialty care at Sanofi. “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.”

The introduction of Kevzara offers a new hope for children suffering from pJIA, aiming to improve their quality of life by managing pain and preventing future joint damage. With this FDA approval, Regeneron and Sanofi continue their efforts to address unmet medical needs in pediatric populations, ensuring that these young patients receive the care and treatment they deserve.

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Resource: Regeneron, June 11, 2024

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