Regeneron and Sanofi’s Dupixent Recommended for Expanded Use in Children with Eosinophilic Esophagitis

Regeneron Pharmaceuticals and Sanofi have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an expanded approval of Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in children aged 1 to 11 years, weighing at least 15 kilograms. This recommendation would allow the use of Dupixent for patients who are inadequately managed by, intolerant to, or not suitable for conventional treatments. The final decision from the European Commission is expected soon. Dupixent is already approved in the European Union (EU) for treating EoE in adults and adolescents aged 12 and older.

This positive recommendation is based on the results of the two-part EoE KIDS Phase 3 clinical trial, which assessed the efficacy of Dupixent in children. In the first part of the trial, a significant number of children receiving weight-adjusted doses of Dupixent achieved histological remission of the disease at 16 weeks, compared to a placebo group. These benefits persisted for up to one year in the second part of the trial. Parents of children treated with Dupixent reported fewer signs of EoE and an improvement in the severity and frequency of symptoms compared to the placebo group.

The safety profile for Dupixent in children was consistent with its known safety in adolescents and adults. The most common adverse effects during the trial were injection site pain, headache, and nausea, while long-term safety was confirmed to be similar to short-term results. The full trial data has been published in The New England Journal of Medicine.

Though the recommendation for Dupixent in younger children is investigational and not yet approved in the EU, this approval would significantly expand treatment options for EoE in children who are often left with limited therapeutic choices. Eosinophilic esophagitis is a chronic and progressive disease driven by type 2 inflammation, which can severely impair a child's ability to eat, causing symptoms like vomiting, abdominal pain, difficulty swallowing, and poor growth.

Dupixent, developed using Regeneron’s VelocImmune® technology, is a monoclonal antibody that blocks the interleukin-4 and interleukin-13 signaling pathways, which are central to type 2 inflammation. This mechanism has proven effective in several inflammatory and allergic diseases, and Dupixent is approved in over 60 countries for a variety of conditions including atopic dermatitis, asthma, and nasal polyps, among others.

Regeneron’s VelocImmune technology was pioneered by the company’s co-founder George D. Yancopoulos and has been pivotal in the creation of several groundbreaking drugs, including REGEN-COV® and Libtayo®. The Dupixent development program, conducted in partnership with Sanofi, has studied the drug in more than 60 clinical trials involving over 10,000 patients.

This expansion of Dupixent’s indications further solidifies its position as a leading treatment for chronic conditions related to type 2 inflammation. Ongoing studies continue to explore its efficacy in additional diseases, including chronic pruritus and bullous pemphigoid, though these potential uses are still under clinical investigation.