FDA approves Kevzara for polyarticular juvenile idiopathic arthritis
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Key takeaways:
- Kevzara is approved for polyarticular JIA in patients weighing 63 kg or greater.
- The drug is an IL-6 inhibitor previously approved for rheumatoid arthritis.
The FDA has approved the interleukin-6 inhibitor Kevzara for the treatment of polyarticular juvenile idiopathic arthritis, according to a press release from Regeneron Pharmaceuticals and Sanofi.
Kevzara (sarilumab; Sanofi, Regeneron) is approved to treat active disease among patients weighing 63 kg or greater.
“Polyarticular juvenile idiopathic arthritis can be a painful disease for children, where multiple joints are impacted by this chronic inflammation,” George D. Yancopoulos, MD, PhD, board co-chair, president and chief scientific officer at Regeneron, said in the 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.”
Evidence supporting the approval came from “adequate and well-controlled studies,” as well as pharmacokinetic data from adults with rheumatoid arthritis, according to the release. A pharmacokinetic, pharmacodynamic, dose finding and safety study was additionally conducted among pediatric patients with polyarticular JIA.
Sarilumab was already approved for the treatment of polymyalgia rheumatica and moderately to severely active rheumatoid arthritis in patients who did not respond to treatment with a disease-modifying antirheumatic drug. No new adverse reactions or safety concerns were observed among patients with polyarticular JIA vs. those with RA.
The most common adverse events among patients with polyarticular JIA were nasopharyngitis, neutropenia, upper respiratory tract infection and injection site erythema, according to the release.
“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,” Brian Foard, executive vice president and head of specialty care at Sanofi, said in the 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.”
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