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FDA accepts Regeneron and Sanofi’s sBLA for Dupixent for priority review
Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has accepted their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) for the treatment of children between one and 11 years old with eosinophilic oesophagitis (EoE).
The target action date for an FDA decision is 31 January 2024. Currently, Dupixent is the first and only treatment approved in the US for children over 12 and adults with EoE.
This sBLA is supported by data from parts A and B of the phase 3 EoE KIDS trial, which assessed the safety and efficacy of Dupixent in children with EoE. Part A of the trial met its primary endpoint of the proportion of patients achieving histological disease remission at 16 weeks for tiered dosing regimens based on body weight, compared to the placebo group. Part B was an active treatment extension period to assess the drug for an additional 36 weeks, and demonstrated that it maintained histologic remission for 52 weeks.
According to the companies’ press release: ‘The potential use of Dupixent in children with EoE aged one to 11 years is currently under clinical development, and its safety and efficacy have not been fully evaluated by any regulatory authority in this setting.’
Safety results in both parts of the trial were consistent with the drug’s known safety profile, and more commonly observed adverse events included COVID-19, rash, headache, viral gastroenteritis, diarrhoea and nausea.
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