In a significant advancement for the treatment of Eosinophilic Oesophagitis (EoE), the European Commission has recently approved Dupixent® (dupilumab) for use in adults and adolescents aged 12 years and over, weighing at least 40kg, who struggle with this chronic, progressive inflammatory disease. Previously, dupilumab was recommended for approval as a treatment for adults and children aged 12 and over in the EU.

It is the first drug approved as a first-line treatment for adults and children older than one year in the US.

This approval marks Dupixent® as the first and only targeted medicine specifically indicated for EoE within the European Union, offering a new ray of hope for approximately 50,000 individuals living with severe, uncontrolled EoE.

What is Eosinophilic Oesophagitis (EoE)

The impact of EoE on a patient’s daily life cannot be overstated – the narrowing and scarring of the oesophagus can make something as simple as eating a painful and distressing experience and may lead to choking and food impaction - Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation at Sanofi

Eosinophilic Oesophagitis (EoE) is a chronic immune system condition that affects the oesophagus, the tube that connects the mouth to the stomach. It happens due to a reaction to certain foods or allergens, resulting in a build-up of eosinophils, a white blood cell, in the oesophagus lining.

This inflammation can lead to scarring, narrowing, and fibrosis of the oesophagus, which can cause difficulty swallowing, food impaction, chest pain, vomiting and poor growth. 
EoE is often associated with other atopic diseases, such as asthma, eczema, and rhinitis, in patients or their families.

Endoscopy and biopsy of the oesophagal tissue are required for diagnosing EoE. Treatment options are limited and include dietary elimination, medication, and dilation of the oesophagus.

Why This Approval Is Important

Early intervention can prevent the development of fibrosis in the oesophagus, leading to a better quality of life, particularly in eating and socialising for patients - Professor Stephen Attwood

EoE can severely impact daily life, making eating a painful and distressing experience due to the narrowing and scarring of the oesophagus. Until now, treatment options were limited, often involving invasive procedures or dietary restrictions without addressing the underlying inflammation driving the disease.

The pivotal trial for Dupixent® showed remarkable results, with around 60% of patients treated experiencing histological disease remission. This signifies not just a reduction in eosinophils but a substantial improvement in patients' ability to swallow.

These findings underscore Dupixent®'s potential to significantly improve the quality of life for those afflicted with EoE.

Dupixent® targets key drivers of type 2 inflammation, interleukin-4 (IL-4) and interleukin-13 (IL-13), which play a central role in EoE and other allergic diseases. 

Safety And Side Effects

The safety and efficacy of Dupixent® were established through a comprehensive 52-week Phase 3 trial, which confirmed its ability to achieve histological remission and reduce swallowing difficulties and showed a favourable safety profile consistent with its use in other indications.

The trial's safety outcomes align with Dupixent®'s established safety profile. Common side effects include injection site reactions, various forms of conjunctivitis, joint pain, oral herpes, and eosinophilia.

EoE patients treated with Dupixent® experienced infections more frequently than those given a placebo (32% vs. 25%), with injection site bruising also noted. Overall, the 52-week safety profile remained consistent with earlier observations.

Read the full article

Q&A With Professor Attwood

EoE Treatment Options

Jorveza® NICE Approval