FDA Assigns Review Date for Dupixent in Young Children with Eosinophilic Esophagitis

The FDA has accepted for priority review Sanofi’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat children 1 to 11 years of age with eosinophilic esophagitis (EoE). The target action date for the FDA decision is Jan. 31, 2024.

Eosinophilic esophagitis is an inflammatory disease that damages the esophagus. In children, common symptoms include heart burn, vomiting, abdominal discomfort, trouble swallowing, food refusal and failure to thrive. These symptoms can impact growth and development and can cause food-related fear and anxiety.

Dupixent, developed by Regeneron Pharmaceuticals and Sanofi, was approved in May 2022 for patients 12 years and older with eosinophilic esophagitis. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways

Dupixent is also approved to treat moderate-to-severe atopic dermatitis, moderate-to-severe asthma, chronic rhinosinusitis with nasal polyposis and the rare skin disease prurigo nodularis.

The sBLA is supported by data from the phase 3 EoE KIDS trial (Parts A and B). In Part A, the primary endpoint was met for the proportion of patients achieving histological disease remission at 16 weeks for tiered dosing regimens based on body weight, compared with 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.

Safety results in Parts A and B of the trial were generally consistent with the safety profile of Dupixent in its EoE indication for children and adults aged 12 years and older. Adverse events more commonly observed with Dupixent were COVID-19, rash, headache, viral gastroenteritis, diarrhea and nausea.