Regeneron, Sanofi: EMA’s CHMP recommends approval of Dupixent in EU

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the approval of Dupixent in the European Union to treat adults and adolescents with eosinophilic esophagitis. This positive opinion covers those who are 12 years and older, weighing at least 40 kg, and inadequately controlled by, are intolerant to or who are not candidates for conventional medicinal therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In May 2022, Dupixent 300 mg weekly was approved by the U.S. FDA for the treatment of patients aged 12 years and older, weighing at least 40 kg.