First-of-a-kind EU approval granted for eosinophilic esophagitis medicine

Dupixent (dupilumab) has been approved by the European Medicines Agency (EMA) as the first treatment for young children with eosinophilic esophagitis in the EU.

This authorisation is based on Phase III data which found that 68 percent of children aged one to 11 years given Dupixent (dupilumab) achieved histological disease remission at 16 weeks. This result was maintained for up to one year.

The biologic treatment is indicated for these individuals “who weigh at least 15kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy”, according to the EMA.

The agency’s decision expands the initial approval of the treatment in the EU for eosinophilic esophagitis in adults and adolescents. The medicine has been jointly developed by Sanofi and Regeneron.

In the Phase III trial, at 16 weeks, in Part A of the study, children given a higher dose of Dupixent based on a weight-based dosing regimen achieved an 86 percent reduction in peak esophageal intraepithelial eosinophil count, the data showed.

What EU approval of Dupixent means for eosinophilic esophagitis patients

“Up to half of all children in the EU with eosinophilic esophagitis remain uncontrolled despite existing standard of care treatment options… This milestone provides an important new treatment for paediatric 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,” explained Dr Houman Ashrafian, PhD, Executive Vice President, Head of Research and Development, Sanofi.

Findings from this Dupixent eosinophilic esophagitis study were published in The New England Journal of Medicine.