Dupixent shows significant histological remission of EoE in young children

Positive Phase III trial results evaluating the investigational use of Dupixent (dupilumab) in children aged one to 11 years with active eosinophilic esophagitis (EoE) were presented today at United European Gastroenterology (UEG) Week 2022, adding to the plethora of solid clinical evidence for the Sanofi (Euronext: SAN) and Regeneron’s (Nasdaq: REGN) developed drug.

The companies plan to submit the data to regulatory authorities around the world, starting with the US Food and Drug Administration (FDA) in 2023. In May 2022, Dupixent 300mg weekly was approved by the US Food and Drug Administration (FDA) to treat EoE in people aged 12 years and older, weighing at least 40kg.

Dupixent led to significant improvements in the primary efficacy measure for higher (n=37) and lower (n=31) dose groups at 16 weeks in the randomized, placebo-controlled Phase III trial. Among children treated with Dupixent, 68% on higher dose and 58% of patients on lower dose achieved the primary endpoint of significant histological disease remission, compared to 3% for placebo (both p<0.0001).