EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
The EU approval follows FDA approval for the same indication in May last year, and builds on prior approvals for other indications such as asthma.
Dupixent is indicated in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.
Building up approvals
Dupixent, which was invented using Regeneron's proprietary VelocImmune technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.
The Dupixent development program has shown ‘significant clinical benefit’ and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.
In the EU, around 50,000 adults and adolescents live with severe uncontrolled EoE. In severe cases a feeding tube may be required.
The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key and central drivers of the type 2 inflammation underlying this disease.
“The impact of EoE on a patient’s daily life cannot be overstated – the narrowing and scarring of the esophagus can make something as simple as eating a painful and distressing experience, and may lead to choking and food impaction,” said Naimish Patel, M.D., Head of Global Development, Immunology and Inflammation at Sanofi.
“With this latest approval for Dupixent, adults and adolescents in the EU suffering from the chronic and often debilitating symptoms of EoE now have the first and only targeted treatment option clinically proven to reduce both esophageal inflammation and damage, as well as improve swallowing ability, pain and health-related quality of life.”
These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and now EoE.
Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the US and Japan. More than 500,000 patients have been treated with Dupixent globally to date.
Regeneron and Sanofi – who are jointly developing dupilumab - say they are committed to investigating the potential of the monoclonal antibody in additional diseases in which IL-4 and IL-13 may play a key role.
To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.
In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials: including pediatric EoE, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritus of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis, and bullous pemphigoid.