FDA Approves Dupixent as First and Only Treatment for Eosinophilic Esophagitis in Children Aged 1 to 11

Jan 26, 2024 08:41 CST Updated 08:41

Sanofi

Pharmaceutical R&D Developer

Regeneron

Biopharmaceutical Manufacturer

On January 26, Sanofi/Regeneron jointly announced that the FDA had approvedDupixent (Dupilumab) New Indication,For ages 1 to 11Eosinophilic Esophagitis（EoE) Treatment of patients. The press release noted,Dupixent is currently the first and only drug in the United States for treating these patients.

EoE is a chronic inflammatory disease that damages the esophagus and prevents it from functioning properly. In children, common symptoms of EoE include acid reflux, vomiting, abdominal discomfort, difficulty swallowing, and growth retardation. These symptoms can affect growth and development and may lead to food-related fear and anxiety.

Dupixent, jointly developed by Sanofi and Regeneron, is an anti-IL-4/IL-13 monoclonal antibody that selectively inhibits the key signaling pathways IL-4 and IL-13, blocks the Th2 inflammatory pathway, reduces pathological responses of Th2 inflammation, thereby treating diseases associated with Th2 inflammation. To date,Dupixent has been approved globally for the treatment of prurigo nodularis, atopic dermatitis, and asthma.Chronic Rhinosinusitis with Nasal Polyps andEosinophilic Esophagitis.In May 2022, Dupixent was approved by the FDAFDA-approved for the treatment of EoE patients aged 12 years and older, weighing ≥40Kg,It is the first and only drug in the United States for the treatment of EoE.

This new indication expansion is primarily based on the positive results from the Phase III EoE KIDS study (Part A and Part B).Part AThe results showed that in16At the same time,66% received weight-based dosingHigher doseDUpixent's pediatric patients (n=32) reached the primary endpoint of histological disease, whileThe placebo group is3%（n=29）。Part B is a 36-week period.Active Treatment Extension Period (n=47), during which from Part ADChildren in the upixent group who met the criteria continued treatment, while those in the placebo group switched toDupixent。The results showed that 53% (17/32) of the patientsHistological Disease RemissionMaintained until52 weeks, including the switch from placebo53% (8/15) of pediatric patients treated with DupixentHistological remission was also achieved.

Part AAndPart B safety results were generally consistent with previous studies.Compared with placebo, the more common adverse events (≥2%) of Dupixent include injection site reactions, upper respiratory tract infections, arthralgia, and herpesvirus infections. In addition,Part B,Dupixent Group Reported 1Example of helminth infection case.

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