CHMP Recommends Dupixent for Pediatric Eosinophilic Esophagitis in the EU
核心洞察
The European Medicines Agency's CHMP has recommended Dupixent (dupilumab) for treating eosinophilic esophagitis (搜索) (EoE) in children aged 1-11 years in the EU.
The recommendation targets children weighing at least 15 kg who have not responded adequately to conventional therapies for their eosinophilic esophagitis (搜索).
The CHMP's positive opinion was based on the EoE KIDS Phase 3 trial, which demonstrated significant histological remission in children treated with Dupixent.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (搜索) (EoE) in children aged 1 to 11 years within the European Union. This recommendation specifically applies to children weighing at least 15 kg who have not responded well to, are intolerant of, or are ineligible for conventional medicinal therapies. The European Commission is expected to make a final decision on the recommendation in the coming months.
Dupixent, developed jointly by Regeneron and Sanofi, is already authorized in the EU for use in adults and adolescents aged 12 years and older with EoE. The CHMP's recommendation is based on data from the EoE KIDS Phase 3 trial.
EoE KIDS Phase 3 Trial
The EoE KIDS trial, a two-part study (Part A and B), involved children aged 1 to 11 years. Part A of the trial demonstrated that a significantly greater proportion of children receiving weight-based doses of Dupixent achieved histological disease remission at week 16, compared to placebo. These results were sustained for up to one year in Part B of the study. Caregivers of children treated with Dupixent also reported improvements in the frequency and severity of EoE signs and symptoms at week 16, with fewer days exhibiting at least one sign of EoE, compared to those on placebo. The data established a bridge, indicating that the response to Dupixent in children with EoE is similar to that observed in approved adult and adolescent EoE populations.
The safety profile of Dupixent in the EoE KIDS study was consistent with its known safety profile in adolescents and adults with EoE. The most common adverse events (AEs) observed in the trial included COVID-19 (搜索), nausea, injection site pain, and headache.
About Eosinophilic Esophagitis
EoE is a chronic, progressive disease characterized by type-2 inflammation, which is believed to damage the esophagus and impair its function. Diagnosing EoE is often challenging, as its symptoms can be mistaken for other conditions, leading to delays in diagnosis. The condition can severely impact a child's ability to eat and thrive, potentially causing vomiting, abdominal pain, difficulty swallowing, decreased appetite, and challenges in growth and development. Continuous management of EoE is often necessary to reduce the risk of complications and disease progression.
Dupixent Mechanism and Prior Approvals
Dupixent (dupilumab) is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (搜索) (IL-4 (搜索)) and interleukin-13 (搜索) (IL-13 (搜索)) pathways, without acting as an immunosuppressant. The Dupixent development program has demonstrated significant clinical benefits and a reduction in type-2 inflammation in Phase 3 studies, confirming that IL-4 and IL-13 are key drivers of type-2 inflammation, which plays a significant role in multiple related and often co-morbid diseases.
Dupixent has already received regulatory approvals in over 60 countries for one or more indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, EoE, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease, across different age populations. Globally, more than 1,000,000 patients are currently being treated with Dupixent.