(CercleFinance.com) – Sanofi indicates that a phase III trial has demonstrated that the efficacy and safety profile of Dupixent, administered for a period of one year to children aged one to 11 years affected of eosinophilic esophagitis, remained constant.
These positive results represent the first analysis of long-term data relating to this age group and will be the subject of a late-breaking communication on October 25, as part of the 2023 Scientific Meeting of the American College of Gastroenterology.
A supplemental biologics license application is currently under priority review in the United States; If approved, Dupixent will be the first and only drug approved by the FDA for this disease in this category of children.