Pharma Focus Asia

Regeneron Pharmaceuticals Introduced Dupixent® First and Only Treatment for Children with Eosinophilic Oesophagitis (EoE)

Regeneron Pharmaceuticals has introduced Dupixent® (dupilumab) for treating paediatric patients aged 1 to 11 years with eosinophilic oesophagitis (EoE), weighing at least 15 kg.

Dupixent, a fully human monoclonal antibody, targets interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways without suppressing the immune system. 

It is the first and only treatment option for EoE patients aged 1 and above, weighing at least 15 kg. By addressing the underlying type 2 inflammation driving this disease, Dupixent has the potential to redefine care standards for these children, akin to its impact on adults and adolescents with EoE.

The approval is based on the Phase 3 EoE KIDS trial, demonstrating a higher proportion of children on Dupixent achieving histological remission compared to placebo.

Eosinophilic Oesophagitis (EoE) is a chronic condition linked with type 2 inflammation, causing damage to the oesophagus and hindering its function. Symptoms such as heartburn, vomiting, abdominal discomfort, swallowing difficulties, food refusal, and failure to thrive can significantly impact a child's well-being and development. 

Continuous treatment is often necessary to mitigate complications and disease progression. Currently, approximately 21,000 children under 12 in the U.S. are undergoing treatment for EoE with unapproved therapies.

Dupixent has secured regulatory approval in over 60 countries, including major regions like Europe, the U.S, and Japan, for treating conditions such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), eosinophilic oesophagitis (EoE), and prurigo nodularis across various age groups. Globally, more than 800,000 patients have benefitted from Dupixent for one or more of these approved indications.

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