Regeneron Pharmaceuticals and Sanofi have received approval from the the US Food and Drug Administration (FDA) for Kevzara (sarilumab) to treat adults with active polyarticular juvenile idiopathic arthritis (pJIA).
The approval is for patients who weigh 63kg or more.
Jointly developed by Sanofi and NASDAQ-listed Regeneron Pharmaceuticals, Kevzara is an injectable prescription medicine that binds specifically to the IL-6 receptor and inhibits IL-6-mediated signalling.
Regeneron Pharmaceuticals chief scientific officer, president, and board co-chair George Yancopoulos said: “Polyarticular juvenile idiopathic arthritis can be a painful disease for children where multiple joints are impacted by this chronic inflammation.
“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 FDA’s approval is backed by evidence from adequate and well-controlled studies, said the companies.
It is also based on pharmacokinetic data from rheumatoid arthritis adult patients and a study covering pharmacokinetics, pharmacodynamics, dose determination, and safety in paediatric patients having pJIA.
The results showed no new adverse reactions or safety issues in the pJIA population compared to the rheumatoid arthritis population.
Among pJIA patients, common adverse drug reactions included nasopharyngitis, neutropenia, upper respiratory tract infection, and injection site erythema.
Neutropenia was the leading cause for discontinuation of Kevzara treatment.
Sanofi speciality care head and executive vice president Brian Foard said: “This latest approval for Kevzara brings a new treatment option with an established efficacy and safety profile to paediatric patients living with polyarticular juvenile idiopathic arthritis.
“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.”
Kevzara is currently approved in 25 countries for moderately to severely active rheumatoid arthritis. In the US, the drug is also approved for polymyalgia rheumatica.
