Sanofi: CHMP recommends EU approval of Dupixent for treatment of eosinophilic esophagitis

(Boursier.com) — Sanofi Indicates that the CHMP recommends the approval of Dupixent (dupilumab) in the EU for the treatment of eosinophilic esophagitis. The Committee of Human Use Medicines of the European Medicines Agency has given a favorable opinion and recommended the approval of Dupixent (Dupilumab) in the European Union (EU) for the treatment of esophagitis with eosinophiles in adults and adolescent. This favorable opinion extends to people from the age of 12, weighing at least 40 kg, inadequately controlled by a conventional medicine, or who are intolerant to it or do not lend themselves to this type of treatment. The European Commission is expected to render its final decision in the coming months. In May 2022, Dupixent 300 mg, once a week, was approved by Food & Drug Administration of the United States for the treatment of eosinophilic eosophagitis of patients from the age of 12, weighing at least 40 kg.

Eosinophilic esophagitis is a chronic, progressive inflammatory disease that impairs the esophagus and its functioning. Eosinophilic esophagitis can sometimes turn the simple act of eating even small amounts into a painful experience with fear of choking. People who suffer from it live in anxiety and frustration of having to constantly modify the list of triggers to avoid. Eosinophilic esophagitis often deteriorates quality of life and increases the risk of depression. When the disease causes a narrowing of the esophagus, its forced dilation, often painful, may be necessary.

If approved, Dupixent will be the first and only targeted medicine indicated specifically for the treatment of eosinophilic esophagitis in patients from 12 years of age in the European Union. In the United States, Dupixent is currently the only drug indicated for the treatment of eosinophilic esophagitis. The recommendation is based on pivotal trial data showing improved swallowing and histological remission in patients treated with Dupixent 300 mg once weekly compared to placebo. In the European Union, nearly 50,000 adults and adolescents suffer from severe, uncontrolled eosinophilic esophagitis.