EC approval for Dupixent in eosinophilic esophagitis

Adding yet another indication for Sanofi (Euronext: SAN) and Regeneron’s (Nasdaq: REGN) blockbuster interleukin (IL)-13 and IL-4 blocking antibody Dupixent (dupilumab), the European Commission (EC) has expanded the marketing authorization to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the USA.

The EC decision is supported by 52-week data from a Phase III trial consisting of three parts (Part A, B and C). These investigated Dupixent 300mg weekly (Part A n=42; Part B n=80) compared to placebo (Part A n=39; Part B n=79) for 24 weeks. Part C (n=188) observed patients who had continued on or switched to Dupixent from Parts A and B for an additional 28 weeks.