Regeneron, Sanofi announce CHMP adopts positive opinion for Dupixent

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending the expanded approval of Dupixent in the European Union for eosinophilic esophagitis n children down to 1 year of age. The recommendation is for children aged 1 to 11 years who weigh at least 15 kg and who are inadequately controlled by, intolerant to, or who are not candidates for conventional medicinal therapy. The European Commission is expected to announce a final decision in the coming months. Dupixent is already approved in the EU for certain adults and adolescents aged 12 years and older with EoE. The positive CHMP opinion is supported by a two-part EoE KIDS Phase 3 trial in children aged 1 to 11 years. In Part A, a significantly greater proportion of children receiving weight-based doses of Dupixent achieved histological disease remission at week 16, compared to placebo, with results sustained for up to one year in Part B. At week 16, caregivers of children treated with Dupixent also observed improvements in the frequency and severity of EoE signs, and fewer days with at least one sign of EoE, compared to placebo. These data established a bridge showing the response to Dupixent in children with EoE is similar to that of the approved adult and adolescent EoE populations. The safety results in the EoE KIDS trial were generally consistent with the known safety profile of Dupixent in adolescents and adults with EoE. AEs more commonly observed with Dupixent in either weight-based dosing regimen compared to placebo during Part A were COVID-19, nausea, injection site pain and headache. The long-term safety profile of Dupixent evaluated in Part B was similar to that observed during Part A. Results from the trial were recently published in The New England Journal of Medicine. The use of Dupixent in children aged 1 to 11 years with EoE is investigational in the EU and is not yet approved.