Sanofi receives positive CHMP opinion for Dupixent in eosinophilic esophagitis

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion, recommending the approval of Dupixentin 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. Food and Drug Administration for the treatment of patients aged 12 years and older, weighing at least 40 kg. The positive CHMP opinion is supported by 52-week data from a Phase 3 trial consisting of three parts – Part A and Part B investigated Dupixent 300 mg weekly compared to placebo for 24 weeks, and Part C observed patients from Parts A and B, all of whom were on Dupixent, having continued on or switched to Dupixent for an additional 28 weeks. The results demonstrated Dupixent-treated patients experienced improvements in their ability to swallow as early as four weeks, as well as histological disease remission, improvements in abnormal endoscopic findings of the esophagus and cellular improvements at 24 weeks compared to placebo, with outcomes maintained up to one year. The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications. Adverse events more commonly observed with Dupixent compared to placebo included infections. The use of Dupixent in adults and adolescents with EoE is investigational in the EU and is not yet approved.