Around 21,000 children under 12 in the U.S. are currently undergoing Eosinophilic Oesophagitis (EoE) treatment. Of these, about 9,000 are not satisfactorily responding to unapproved therapies, indicating a need for more advanced alternative treatment options. 

In a significant step forward for paediatric EoE treatment, the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for Dupixent (dupilumab). Dupixent is currently FDA-approved for patients with EoE aged 12 years and older who weigh at least 40kg.

This application aims to extend the use of Dupixent to treat EoE in children between the ages of 1 and 11 and if approved will become the first treatment in the world for use in this age group.

Priority review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of severe conditions.

The potential use of Dupixent in younger children with EoE is currently under clinical development, and any regulatory authority still needs to fully evaluate its safety and efficacy in this setting. Dupixent can become the first and only FDA-approved treatment for children aged 1 to 11 with EoE.

About Dupixent

Dupixent is not new to the world of biological treatments. Already approved for other allergic and inflammatory conditions, the medication works by inhibiting the activity of interleukin-4 and interleukin-13. These are key drivers of type 2 inflammation, which is implicated in EoE and several other allergic diseases.

These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and EoE.

Because of this target action, Dupixent could offer a more targeted treatment approach than existing options, especially relevant for those suffering from multiple atopic/allergic or eosinophilic diseases.

Recent studies have shown promising results for Dupixent in treating EoE. The drug has produced stronger histologic, symptomatic, endoscopic, and molecular improvements than other treatments. Its efficacy in managing EoE symptoms has sparked significant interest in the medical community and patients navigating this complex condition.

About Eosinophilic Oesophagitis (EoE)

Eosinophilic Oesophagitis (EoE) is a chronic condition where eosinophils, a type of white blood cell, build up in the oesophagus. This often leads to swallowing difficulties, food impactions, and nutritional issues. 

It brings unique challenges in paediatric patients, affecting the child and the entire family. 

What This Means For The Eosinophilic Community

For families and healthcare providers coping with paediatric EoE, the Priority Review for Dupixent’s sBLA is a beacon of hope. 

Many children are currently using treatments not officially approved for EoE; for some, these treatments aren’t working well enough. This leads to uncertainty and stress for both the patients and their families.

The development marks a significant advancement in treatment possibilities, especially for those who have exhausted other therapeutic options. 

Around 80% of our community has one or more other atopic conditions such as asthma, eczema, dermatitis, rhinitis, etc, living with these multiple conditions can often be severely life-impacting. 

Read the stories of people living with Eosinophilic-Associated Diseases.

However, every treatment comes with its set of challenges. For Dupixent, the considerations could include cost, and insurance challenges, as newer treatments may come with a higher price tag. 

This financial burden may be particularly significant for families already managing the emotional and logistical challenges of Eosinophilic-Associated Diseases.

Additionally, the treatment may not be globally accessible, creating disparities in healthcare access. Its long-term efficacy and potential side effects must also be closely monitored, adding another layer of complexity for healthcare providers and families.

Parents and caregivers must choose the best care path for their family with their healthcare provider. Having an approved treatment would give new options for what in the past has been a minimal choice of repurposed off-label medications designed for treating asthma. 

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