FDA has approved Dupixent® (dupilumab) for children in the United States aged one to eleven, weighing at least 15 kg, with Eosinophilic Oesophagitis (EoE).

Dupixent is now the first and only FDA-approved US treatment specifically for this young age group, providing hope for countless families. 

This latest approval for Dupixent builds on its initial FDA nod in May 2022 for EoE patients from twelve years old, weighing at least 40 kg, expanding its use to younger children. 

The FDA prioritised its review based on the Phase 3 EoE KIDS trial, showing that a more significant proportion of children taking Dupixent achieved histological remission than placebo.

This marks a historic moment for EoE management in young children from one year old.

Efficacy Proven in EoE KIDS Trial

The Phase 3 EoE KIDS trial significantly influenced Dupixent's approval. The study demonstrated the drug's effectiveness in reducing eosinophil counts and alleviating the symptoms of EoE, such as stomach pain, vomiting, and food refusal. These results signify a step forward in the therapeutic management of EoE in children who have had limited options until now.

About Dupixent

Dupixent, developed using Regeneron's VelocImmune® technology, is a monoclonal antibody targeting the IL-4 and IL-13 pathways, crucial in type 2 inflammation. Dupixent is approved in the U.S. for multiple conditions. 

It treats moderate-to-severe eczema in adults and children over six months, certain asthma types in those older than 6, and chronic rhinosinusitis with nasal polyposis in adults. It's also used for EoE in adults and children over one year and treating prurigo nodularis in adults. The safety and efficacy of Dupixent for some of these conditions in younger patients are yet to be established. 

Why The News Is Important For The Young Patients

EoE is a chronic and progressive disease, often linked to type 2 inflammation, causing damage and functional impairment of the oesophagus. It affects a child's eating ability, leading to symptoms like heartburn, vomiting, and difficulty swallowing. These issues can significantly hinder growth and development. 

Treatment is necessary to mitigate complications and disease progression. It's estimated that around 21,000 U.S. children under 12 are treated for EoE, often with therapies not officially approved for the condition. The actual number affected may be higher due to misdiagnosis and delayed diagnosis.

Naimish Patel, M.D., from Sanofi, highlights the significant unmet medical needs of young EoE patients. Despite existing treatments, many children under 12 continue to suffer from EoE symptoms. He emphasises that the FDA's approval of Dupixent not only aligns with Sanofi's commitment to addressing these needs but also offers hope to young patients at a crucial developmental stage where proper nutrition and growth are directly impacted by their ability to eat.

Impact Beyond EoE

The approval of Dupixent extends beyond just EoE. It highlights the drug's role in managing conditions driven by type 2 inflammation, emphasising the importance of targeted therapy in pediatric medicine. This development is a win for those battling EoE and the broader medical community, as it paves the way for more focused and effective treatments for various inflammatory conditions.

Please visit Regeneron's official announcement for in-depth information on this significant advancement in Eosinophilic disease treatment.