FDA Approves Dupixent as First and Only Treatment for Children Aged 1 to 11 with Eosinophilic Esophagitis (EoE)

On January 26, Sanofi/Regeneron jointly announced that the FDA has approved Dupixent (dupilumab) for a new indication, treating eosinophilic esophagitis (EoE) in patients aged 1 to 11. The press release noted that Dupixent is currently the first and only drug in the U.S. approved for treating these patients.

EoE is a chronic inflammatory disease that damages the esophagus and prevents it from functioning properly. Common symptoms of EoE in children 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, and reduces pathological responses of Th2 inflammation, thereby treating diseases associated with Th2 inflammation. To date, Dupixent has been approved worldwide for the treatment of prurigo nodularis, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis (EoE). In May 2022, Dupixent received FDA approval for the treatment of EoE patients aged 12 years and older with a body weight ≥40Kg, making it the first and only drug in the United States for the treatment of EoE.

The expansion of the new indication this time is mainly based on the positive results of the Phase III EoE KIDS study (Part A and Part B). The results of Part A showed that at 16 weeks, 66% of children (n=32) receiving the higher dose of Dupixent based on body weight achieved the primary endpoint for histological disease remission, compared to 3% in the placebo group (n=29). Part B was a 36-week active treatment extension period (n=47), during which eligible children from the Dupixent group in Part A continued treatment, while those in the placebo group switched to Dupixent. The results showed that 53% (17/32) of patients maintained histological disease remission up to 52 weeks, and 53% (8/15) of children who switched from placebo to Dupixent also achieved histological remission.

The safety results of Part A and Part B were generally consistent with previous studies. Compared with placebo, more common adverse events (≥2%) associated with Dupixent included injection site reactions, upper respiratory tract infections, arthralgia, and herpesvirus infections. Additionally, in Part B, one case of helminth infection was reported in the Dupixent group.

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