CHMP Recommends EU Approval of Dupixent for Eosinophilic Esophagitis in Children 1+

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a favorable recommendation for the expanded approval of Dupixent (dupilumab) in the EU for treating eosinophilic esophagitis (EoE) in children as young as one year old. This recommendation targets children aged 1 to 11 years who weigh at least 15 kg and who do not respond adequately to, are intolerant of, or are not suitable candidates for conventional medicinal treatments. The final decision from the European Commission is expected in the upcoming months. Currently, Dupixent is already approved in the EU for adults and adolescents aged 12 years and above with EoE.

The positive recommendation from CHMP is based on the results of a two-part phase 3 study, named EoE KIDS, which involved children aged one to 11 years. Part A of the study showed that a significantly higher percentage of children receiving weight-based doses of Dupixent achieved histological remission of the disease at week 16 compared to those on a placebo. These results were sustained for up to one year in Part B of the study. At the 16-week mark, caregivers noted improvements in the severity and frequency of EoE symptoms in children treated with Dupixent. These data show that the response to Dupixent in young children is similar to that observed in adults and adolescents.

In terms of safety, the EoE KIDS study found that the adverse events observed in children were generally in line with the known safety profile of Dupixent in both adolescents and adults. More common side effects with Dupixent (≥10%) in either weight-based dosing regimen compared to placebo included COVID-19, nausea, injection site pain, and headache. The long-term safety profile in Part B of the study was consistent with that observed in Part A.

The findings from this study were recently published in The New England Journal of Medicine.

EoE is a chronic, progressive disease characterized by type-2 inflammation, which damages the esophagus and impairs its function. Diagnosing EoE can be challenging as symptoms might be mistaken for other conditions, leading to delays. EoE can significantly affect a child’s ability to eat, potentially causing vomiting, abdominal pain, difficulty swallowing, decreased appetite, and difficulties in achieving normal growth. Continuous management is often necessary to reduce the risk of complications and disease progression.

Dupixent is a fully human monoclonal antibody that blocks the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. Clinical studies have shown that Dupixent significantly reduces type-2 inflammation, which is central to multiple related and often co-morbid diseases. Dupixent has received regulatory approval in more than 60 countries for various indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, EoE, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease across different age groups. Globally, over 1,000,000 patients have been treated with Dupixent.

The development of dupilumab, the active ingredient in Dupixent, is a collaborative effort between Sanofi and Regeneron. To date, dupilumab has been studied in more than 60 clinical trials involving over 10,000 patients with various chronic diseases driven by type-2 inflammation. Sanofi and Regeneron are also investigating additional potential uses for dupilumab in conditions such as chronic pruritus of unknown origin and bullous pemphigoid. However, these potential uses are still under clinical investigation and have not been fully evaluated for safety and efficacy by any regulatory authority.