Regeneron, Sanofi announce FDA acceptance for Priority Review of Dupixent sBLA

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for Priority Review the supplemental Biologics License Application, or sBLA, for Dupixent to treat children aged one to 11 years with eosinophilic esophagitis, or EoE. The target action date for the FDA decision is January 31, 2024. Dupixent is the first and only treatment in the U.S. approved for children and adults aged 12 years and older with EoE, weighing at least 40kg. The sBLA is supported by data from the Phase 3 EoE KIDS trial evaluating the efficacy and safety of Dupixent in children aged one to 11 with EoE. In Part A, the primary endpoint was met for the proportion of patients achieving histological disease remission (defined as peak esophageal intraepithelial eosinophil count of six eosinophils (eos)/high power field (hpf)) at 16 weeks for tiered dosing regimens based on body weight, compared to placebo. Part B was an active treatment extension period evaluating Dupixent for an additional 36 weeks and showed Dupixent maintained histologic remission for 52 weeks, a secondary endpoint. Dupixent also led to increases in body weight for age percentile, which was evaluated as an exploratory endpoint in Part A and a secondary endpoint in Part B. Safety results in Parts A and B of the trial were generally consistent with the known safety profile of Dupixent in its FDA-approved EoE indication for children and adults aged 12 years and older who weigh at least 40kg. Adverse events more commonly observed with Dupixent compared to placebo were COVID-19, rash, headache, viral gastroenteritis, diarrhea and nausea. Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. The potential use of Dupixent in children with EoE aged 1 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.