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FDA Approves Regeneron and Sanofi’s Kevzara to Treat Patients with Active Polyarticular Juvenile Idiopathic Arthritis

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Approval for Kevzara was based on controlled studies, pharmacokinetic data from adults with rheumatoid arthritis, and pediatric-specific studies on pharmacokinetics.

Man, joint pain and elbow arthritis in outdoor closeup in summer sunshine with massage arms. Broken arm, bone and guy at urban park in metro, city or town with physical therapy with hands in zoom. Image Credit: Adobe Stock Images/Clement C/peopleimages.com

Image Credit: Adobe Stock Images/Clement C/peopleimages.com

The FDA has approved Regeneron’s and Sanofi’s approved Kevzara (sarilumab) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients weighing over 138 lbs. According to a joint press release, the approval was based on results of controlled studies and pharmacokinetic data from adults with rheumatoid arthritis (RA), as well as pediatric-specific studies on pharmacokinetics, pharmacodynamics, dosing, and safety.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, chief scientific officer, Regeneron, in a press release. "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.”

Kevzara was first approved by the FDA in 2017 for the treatment of adults with moderately to severely active RA who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate Kevzara, a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), is also indicated for adults with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. IL-6 is an immune system protein produced in increased quantities in patients with RA and is associated with disease activity, joint destruction, and other systemic issues.2,3

In the latest indication for Kevzara, no new adverse events (AEs) were found in patients with pJIA compared to patients with RA. Common AEs included nasopharyngitis, neutropenia, upper respiratory tract infections, and injection site erythema, and serious infections being 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.1

According to a study published in the National Library of Medicine, pJIA can begin any time before the age of 16 years but rarely occurs before the first year of life. In the case of rheumatoid factor (RF)-negative pJIA, a patient will experience a peak between the ages of 1-3 years, with a second peak occurring between the ages of 9-14 years. pJLA is more common in girls, with the study suggesting a diagnosis rate between two to four times higher than that of boys.

On the other end, RF-positive JIA appears to be more common in older children. The disease tends to manifest between the ages of 10-13 years and is considerably more common in girls than in boys. Other current treatments include nonsteroidal anti-inflammatory drugs, glucocorticoids, systemic glucocorticoids, leflunomide, and several other DMARDs. A number of biologics are also used in the treatment of pJIA.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, EVP, head, specialty care, Sanofi, in a press release. “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.”

References

1. KEVZARA® (SARILUMAB) APPROVED BY FDA FOR THE TREATMENT OF ACTIVE POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS (PJIA). Regeneron. June 11, 2024. Accessed June 11, 2024. https://investor.regeneron.com/news-releases/news-release-details/kevzarar-sarilumab-approved-fda-treatment-active-polyarticular

2. Sanofi and Regeneron Announce FDA Approval of Kevzara® (sarilumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients. Sanofi. May 22, 2017. Accessed June 11, 2024. https://www.sanofi.com/en/media-room/press-releases/2017/2017-05-22-21-52-05-994893

3. Kevzara. Kevzara. Accessed June 11, 2024. https://www.kevzarahcp.com/

4. Polyarticular juvenile idiopathic arthritis – epidemiology and management approaches. National Library of Medicine. October 24, 2014. Accessed June 11, 2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4216020/#:~:text=16%2C17%2C20%2C21,frequencies%20approaching%20or%20exceeding%2050%25.

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