In late January 2024, the U.S. Food and Drug Administration approved a label expansion for Dupixent (dupilumab). Dupixent, a monoclonal antibody targeting IL-4 and IL-13, is currently used to treat eosinophilic esophagitis (EoE), prurigo nodularis, and a number of allergic and immune-mediated diseases. According to an article from Tristan Manalac in Biospace, the new approval covers Dupixent for EoE in children between ages 1-11 who weigh at least 15kg (approx. 33.08 pounds).
The approval follows data from the Phase 3 EoE KIDS clinical study. Within the study, researchers explored the impact of Dupixent on inducing remission in children with EoE. The study results found that 66% of those receiving Dupixent achieved remission by the 16-week point, whereas only 3% of those receiving the placebo met the same mark. Once all patients were switched to Dupixent, 53% of individuals who were non-responders on the placebo achieved remission.
Dupixent’s approval for children ages 1-11 could significantly and meaningfully benefit this community. An estimated 40% of children within this age group still experience symptoms regardless of treatment. As a result, Dupixent could mitigate symptoms and allow these children to experience a higher quality-of-life.
About Eosinophilic Esophagitis (EoE)
Eosinophilic esophagitis is a chronic and immune-mediated digestive system disorder. Eosinophils are a type of white blood cells that helps fight infections; a high accumulation of eosinophils is characteristic of certain allergic conditions. These eosinophils can also cause inflammation by releasing substances into surrounding tissues. In eosinophilic esophagitis, large amounts of eosinophils collect in the esophagus. Chronic esophageal inflammation leads to many of the symptoms associated with this condition, such as dysphagia (difficulty swallowing), nausea and vomiting, food impaction (food getting stuck in the throat), failure to thrive (poor growth; unintentional weight loss), appetite loss, malnutrition, and abdominal pain.
Doctors don’t know exactly what causes EoE but it is often considered immune-mediated. There’s a widespread belief that eosinophilic esophagitis could result from immune hypersensitivity to allergens; another hypothesis says that EoE could result from a blend of genetic predisposition and environmental triggers. People with eosinophilic esophagitis also often have conditions like asthma and eczema.
