Dupixent Receives FDA Priority Review for Expanded Indication in Children Aged 1 to 11 with Eosinophilic Esophagitis

On September 26, Regeneron announced that the FDA has accepted the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) for the treatment of EoE (eosinophilic esophagitis) in patients aged 1 to 11 years and granted it Priority Review, with a PDUFA date set for January 31, 2024.

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, and 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, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis.

In May 2022, Dupixent was approved by the FDA 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. This sBLA is primarily based on the positive results from the Phase III EoE KIDS study (Part A and Part B).

Part A: The primary endpoint was the proportion of patients achieving histological disease remission at 16 weeks. A total of 102 children aged 1 to 11 years with EoE were randomly assigned to receive Dupixent treatment, using either a higher weight-based dose (n=37) or a lower dose (n=31), or placebo (n=34). The results showed that at 16 weeks, 68% of children on the higher dose and 58% on the lower dose achieved the primary endpoint of significant histological disease remission, compared to 3% in the placebo group (p<0.0001). Part B: The active treatment extension period demonstrated that Dupixent could maintain histological disease remission for 52 weeks.

The safety results of Part A and Part B were generally consistent with previous studies. Compared with placebo, the more common adverse events (≥5%) associated with Dupixent included COVID-19, rash, headache, viral gastroenteritis, diarrhea, and nausea.

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