The European Commission has granted approval for Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in children aged 1 to 11 years, weighing a minimum of 15 kg. This approval marks a significant advancement in the treatment of EoE, providing a much-needed option for young patients who do not respond adequately to conventional therapies.
The approval is based on the results of the Phase 3 EoE KIDS trial, a randomized, double-blind, placebo-controlled study. The trial demonstrated that 68% of children treated with Dupixent achieved histological disease remission at 16 weeks, compared to only 3% in the placebo group (p<0.0001). Histological remission was defined as ≤6 eosinophils/high power field.
Significant Reduction in Eosinophil Count
In addition to histological remission, Dupixent also showed an 86% reduction in peak esophageal intraepithelial eosinophil count from baseline, compared to a 21% increase in the placebo group. This substantial reduction in eosinophil count underscores the drug's effectiveness in targeting the underlying inflammation associated with EoE.
Safety Profile
The safety profile of Dupixent in the EoE KIDS trial was consistent with previous studies in adolescents and adults with EoE. The most common adverse reactions included injection site reactions, conjunctivitis, and eosinophilia. In patients aged 1 to 11 years, adverse events more commonly observed with Dupixent (≥10%) compared to placebo during Part A were COVID-19, nausea, injection site pain and headache.
Addressing Unmet Needs
EoE is a chronic, progressive disease driven by type 2 inflammation, which damages the esophagus and impairs its function. Symptoms can include vomiting, abdominal pain, difficulty swallowing, and decreased appetite, severely impacting a child’s ability to eat and thrive. Up to half of all children in the EU with EoE remain uncontrolled despite existing standard of care treatment options.
According to Houman Ashrafian, M.D., Ph.D., Executive Vice President, Head of Research and Development at Sanofi, this approval 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."
Dosing and Administration
Dupixent is administered via subcutaneous injection. In patients aged 1 to 11 years with EoE, the dosing regimen is either every other week (200 mg for children ≥15 to <30 kg, 300 mg for children ≥30 to <40 kg) or every week (300 mg for children ≥40 kg), based on weight. The injection can be administered in a clinic or at home by a caregiver after proper training.
About Dupixent
Dupixent, invented using Regeneron’s VelocImmune technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. It is not an immunosuppressant. Dupixent has received regulatory approvals in more than 60 countries for various indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.
Regeneron and Sanofi are jointly developing dupilumab under a global collaboration agreement. They are also studying dupilumab in Phase 3 trials for chronic pruritus of unknown origin and bullous pemphigoid.
