Sanofi gets EMA panel recommendation for Dupixent to treat eosinophilic esophagitis
EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
Paris: Sanofi has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of Dupixent (dupilumab) in the European Union (EU) to treat adults and adolescents with eosinophilic esophagitis (EoE).
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.
EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. The results seen with Dupixent in adults and adolescents with EoE demonstrate that interleukin-4 (IL-4) and interleukin-13 (IL-13) are key and central drivers of the type 2 inflammation underlying this disease. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life, and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition.
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.
Read also: Sanofi Dupixent gets European Commission nod for Prurigo Nodularis
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