CHMP Recommends Dupixent for Younger Eosinophilic Oesophagitis Patients

Sanofi and Regeneron’s Dupixent (dupilumab) has garnered a recommendation from the European Medicines Agency’s human medicines committee for the treatment of younger eosinophilic oesophagitis (EoE) patients. The Committee for Medicinal Products for Human Use (CHMP) has suggested that Dupixent be authorized for children aged one to eleven years who weigh at least 15kg and are not adequately managed by, are intolerant to, or are unsuitable candidates for conventional medicinal therapies.

Upon approval by the European Commission, Dupixent would stand as the first and exclusive medicine in the European Union indicated for treating EoE in this younger demographic. This recommendation is substantiated by positive results from the phase 3 EoE KIDS trial. In this trial, a significantly higher proportion of children receiving Dupixent achieved histological disease remission at week 16 compared to those on a placebo, with these results being sustained for up to a year. Additionally, improvements in the frequency and severity of EoE symptoms were noted in patients treated with Dupixent, and the safety profile was generally consistent with what is already known for adult and adolescent patients.

EoE is a chronic inflammatory condition characterized by symptoms such as difficulty swallowing, vomiting, and pain. Dupixent is already approved in the EU for treating certain EoE patients aged 12 years and older. This fully human monoclonal antibody functions by inhibiting the signaling of the interleukin-4 and interleukin-13 pathways. The Dupixent development program has demonstrated that these pathways are central to the type 2 inflammation that underlies multiple related diseases.

Beyond its application for EoE, Dupixent is approved to treat a variety of conditions including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease (COPD). Most recently, the U.S. Food and Drug Administration granted approval for Dupixent as an add-on maintenance treatment for adolescents with CRSwNP, a chronic upper airway disease that obstructs the sinuses and nasal passages. Furthermore, the Medicines and Healthcare products Regulatory Agency approved Dupixent this month as an add-on maintenance treatment for COPD.