Dupixent Approved by CHMP for Treating EoE in Children 1+

Regeneron Pharmaceuticals, Inc. and Sanofi have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed the expanded approval of Dupixent® (dupilumab) in the European Union 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 are inadequately managed by, intolerant to, or not candidates for standard medicinal therapies. The European Commission is anticipated to finalize its decision in the coming months. Dupixent is already approved in the EU for EoE in adults and adolescents aged 12 years and older.

The CHMP's positive opinion stems from data obtained from a Phase 3 trial named EoE KIDS, which included children aged 1 to 11 years. The trial consisted of two parts (Part A and B). In Part A, children receiving weight-based doses of Dupixent showed a significantly higher rate of histological disease remission at week 16 compared to those on placebo. These positive effects were sustained for up to one year in Part B. Additionally, caregivers reported improvements in the frequency and severity of EoE symptoms, as well as fewer days with at least one symptom, compared to placebo. The data demonstrated that the response in children mirrored the positive outcomes seen in adults and adolescents.

The safety profile of Dupixent in the EoE KIDS trial was consistent with the established safety data in older populations. Common adverse events (AEs) observed with Dupixent (≥10%) included COVID-19, nausea, injection site pain, and headache. The long-term safety profile evaluated over the course of the trial remained similar.

Eosinophilic esophagitis is a chronic and progressive condition driven by type 2 inflammation, which damages the esophagus and impairs its function. Symptoms often resemble other conditions, leading to diagnostic delays. EoE can significantly affect a child's eating ability, causing issues like vomiting, abdominal pain, difficulty swallowing, decreased appetite, and general failure to thrive. Continuous management is crucial to mitigate complications and disease progression.

Dupixent, formulated using Regeneron’s VelocImmune® technology, is a fully human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways. It is not an immunosuppressant. The Dupixent development program has shown substantial clinical benefits by reducing type 2 inflammation, with IL-4 and IL-13 identified as central drivers in various type 2 inflammatory diseases.

Dupixent has received approvals in over 60 countries for multiple indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, EoE, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease (COPD) in different age groups. Over a million patients worldwide are currently being treated with Dupixent.

Regeneron's VelocImmune technology utilizes a genetically engineered mouse platform with a humanized immune system to produce optimized fully human antibodies. This technology has been instrumental in creating numerous FDA-approved antibodies, including REGEN-COV® (casirivimab and imdevimab), Dupixent, Libtayo® (cemiplimab-rwlc), and several others. Dupilumab, the active ingredient in Dupixent, is being co-developed by Regeneron and Sanofi under a global collaboration agreement, and has been evaluated in over 60 clinical trials involving more than 10,000 patients with various chronic diseases driven by type 2 inflammation.

In addition to its current indications, Dupixent is being studied in a range of diseases related to type 2 inflammation or other allergic processes, including chronic pruritus of unknown origin and bullous pemphigoid. These investigational uses are still undergoing clinical evaluation, and their safety and efficacy have not been fully established.

Regeneron is a leading biotechnology firm committed to developing life-transforming medicines for serious diseases. The company leverages proprietary technologies like VelociSuite® and data-driven insights from the Regeneron Genetics Center® to advance the next generation of medical treatments.