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The European Commission has approved Regeneron and Sanofi’s Dupixent (dupilumab) for treating eosinophilic esophagitis in children aged 1 to 11 years and weighing at least 15 kg who have not responded to standard therapies.

This approval makes Dupixent the first and only treatment available in Europe for the pediatric population with this chronic inflammatory condition.

It also signifies a broadening of the age group that can use the medicine after its last year’s approval for use in adults and adolescents living with severe uncontrolled eosinophilic esophagitis in the European Union.

“This approval will bring the proven efficacy and demonstrated safety profile of Dupixent to this vulnerable, young population that has already been established in older eosinophilic esophagitis patients and has the potential to transform the standard of care for children with the disease who previously had no therapies specifically approved for them,” stated George Yancopoulous, M.D., Chief Scientific Officer, Regeneron.

Dupilumab, jointly developed by Regeneron and Sanofi under a worldwide partnership deal, is a subcutaneously injected human monoclonal antibody that limits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, causing a decrease in type 2 inflammation and related conditions.

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It has received approval in over 60 countries, including the U.S. and Canada, for conditions including atopic dermatitis, asthma, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and more.

The approval is based on results from a Phase III trial coded EoE KIDS, which showed that substantially more children aged between 1 and 11 years on Dupixent achieved histological disease remission at approximately 16 weeks compared to a placebo, which was administered for up to one year.

The observed efficacy and safety data were similar to those of the approved adult and adolescent populations.

“This milestone provides an important new treatment for pediatric patients who were previously without options specifically approved for their disease. With this novel approach to addressing an underlying cause of eosinophilic esophagitis, Dupixent has the potential to give these young children a better chance to thrive,” emphasized Houman Ashrafian, M.D., Executive Vice President, Sanofi.

Regeneron and Sanofi are carrying out dupilumab studies in a wide range of disease conditions caused by type 2 inflammation including chronic pruritus of unknown origin.

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