CHMP Recommends Dupixent for EU Approval to Treat Eosinophilic Esophagitis in Children from 1 Year

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 aged 1 to 11 years. This recommendation is for children weighing at least 15 kg who do not respond well to, are intolerant of, or are unsuitable for conventional medication. The European Commission's final decision is anticipated in the upcoming months. Dupixent is already approved in the EU for certain adults and adolescents aged 12 years and older with EoE.

The CHMP's positive opinion is backed by a two-part Phase 3 study known as EoE KIDS, involving children aged one to 11 years. In the first part of the study (Part A), a significantly higher proportion of children receiving weight-based doses of Dupixent achieved histological disease remission at week 16 compared to those on a placebo. The results were sustained for up to a year in the second part (Part B). Caregivers also reported improvements in the frequency and severity of EoE symptoms and fewer days with at least one symptom in children treated with Dupixent. These findings align with improvements seen in adults and adolescents who are already approved for Dupixent.

The safety profile of Dupixent observed in the EoE KIDS study was consistent with its known safety profile in older patients. Common adverse events observed with Dupixent (≥10%) in either weight-based dosing regimen compared to placebo during Part A were COVID-19, nausea, injection site pain, and headache. The long-term safety profile evaluated in Part B was similar to that seen in Part A.

The study results were recently published in The New England Journal of Medicine. It is important to note that the use of Dupixent in children aged 1 to 11 years with EoE is still investigational in the EU and has not yet been approved.

EoE is a chronic, progressive disease characterized by type-2 inflammation, which damages the esophagus and impairs its function. Diagnosing EoE is challenging due to symptom overlap with other conditions, leading to delays in diagnosis. The disease can severely impact a child’s ability to eat, causing symptoms such as vomiting, abdominal pain, difficulty swallowing, decreased appetite, and growth challenges. Continuous management is essential to reduce the risk of complications and disease progression.

Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of interleukin-4 (IL4) and interleukin-13 (IL13) pathways, without being an immunosuppressant. Clinical trials have shown that Dupixent significantly benefits patients by reducing type-2 inflammation, which is central to many chronic diseases. Dupixent has received regulatory approvals 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. Over one million patients globally are being treated with Dupixent.

The development of dupilumab is a collaborative effort between Sanofi and Regeneron. To date, it has been studied in over 60 clinical trials involving more than 10,000 patients with various chronic diseases associated with type-2 inflammation. Beyond currently approved indications, Sanofi and Regeneron are exploring dupilumab for a range of diseases driven by type-2 inflammation or other allergic processes, including chronic pruritus of unknown origin and bullous pemphigoid, in Phase 3 studies.

Regeneron is a biotechnology company dedicated to developing life-transforming medicines for severe diseases. Its proprietary technologies, such as VelociSuite®, and data-driven insights from the Regeneron Genetics Center®, are at the forefront of scientific discovery and drug development. Sanofi, an innovative global healthcare company, aims to improve lives through groundbreaking treatment options and vaccine protection, emphasizing sustainability and social responsibility in its endeavors.