EMA Approves Dupixent as Treatment for Eosinophilic Esophagitis in Children

The European Medicines Agency has authorized Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in children starting from one year old. The approval specifically pertains to children between the ages of one and 11 years who weigh a minimum of 15 kg and who are either inadequately managed by, intolerant of, or not suitable for standard medical treatment. This broadens the original authorization in the European Union (EU) for EoE in adolescents and adults, establishing Dupixent as the first and sole medication approved for these younger patients.

Roberta Giodice,  president, ESEO Italia, said: “Young children with eosinophilic esophagitis are at the beginning of their life-long journey with a disease that challenges their ability to eat. Parents of these children have often relied on restrictive diets that do not specifically address the disease and can stunt their growth at a critical time in development that could impact them for years to come. We are pleased that research continues and offers new treatment options to improve the quality of their care.”

Houman Ashrafian, MD, PhD, executive vice president, head of research and development, Sanofi, said: “Up to half of all children in the EU with eosinophilic esophagitis remain uncontrolled despite existing standard of care treatment options, and, as a result, many of these young patients struggle to maintain weight due to serious symptoms such as difficulty swallowing and vomiting. 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.”