Sanofi Dupixent sBLA for treatment of eosinophilic esophagitis in children aged 1 to 11 accepted for USFDA priority review
Paris: Sanofi has announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat children aged 1 to 11 years with eosinophilic esophagitis (EoE).
The target action date for the FDA decision is January 31, 2024. Dupixent is a 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 (Parts A and B) evaluating the efficacy and safety of Dupixent in children aged 1 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 ≤6 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.
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