FDA Approves Dupixent in Young Children with Eosinophilic Esophagitis

The FDA has approved Sanofi’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat children 1 to 11 years of age with eosinophilic esophagitis (EoE) weighing at least 15 kg. 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.

Dupixent, developed by Regeneron Pharmaceuticals and Sanofi, was approved in May 2022 for patients 12 years and older with eosinophilic esophagitis weighing at least 40 kg. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways.

The FDA approval is based on data from the phase 3 EoE KIDS trial with two parts evaluating the efficacy and safety of Dupixent in children aged 1 to 11 years with EoE. At 16 weeks, 66% of the 32 children who received higher dose Dupixent at tiered dosing regimens based on weight achieved histological disease remission, the primary endpoint, compared with 3% for placebo. Remission was sustained at week 52, with 17 of 32 children treated with Dupixent. Remission was also achieved at week 52 in 8 of 15 children who switched to Dupixent from placebo.

The safety profile in in children aged 1 to 11 years weighing at least 15 kg was generally similar to the safety profile of Dupixent in adult and pediatric patients aged 12 years and older with EoE. The most common adverse events were injection site reactions, upper respiratory tract infections, arthralgia (joint pain) and herpes viral infections.

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 list price of Dupixent is $3,803.20 per carton. For commercial patients, Sanofi offers a $0 copay card with an annual limit of $13,000. The company also offer patient assistance for those who qualify.