Dupixent (dupilumab) is currently the first and only FDA-approved treatment for eosinophilic esophagitis (EoE) in people ages 12 or older who weigh at least 40 kg (88.18 pounds). The developer of the biologic, Regeneron Pharmaceuticals, is currently exploring Dupixent as a potential therapeutic option for children ages 1-11 with EoE. The company submitted a supplemental Biologics License Application (sBLA) to the FDA for review. Learn more about the BLA and sBLA process.
According to a relatively recent news release, the FDA granted Priority Review designation to the sBLA. Priority Review status essentially means that the FDA will take action on an application in 6 months, compared to the normal 10-month review period. As of now, the FDA plans to offer a decision on Dupixent by January 31, 2024.
Evaluating Dupixent
Dupixent is a fully human monoclonal antibody and interleukin-4 receptor alpha antagonist. The drug also inhibits interleukin-13 signaling. Both interleukins play a role in type 2 inflammation, a type of overactive immune response seen in EoE. Outside of EoE, Dupixent is also used or being evaluated for conditions such as prurigo nodularis, atopic dermatitis, and chronic rhinosinusitis with nasal polyposis.
The sBLA was granted Priority Review following the release of data from the Phase 3 EoE KIDS study. Within the study, researchers sought to understand how safe and effective the treatment was within the younger patient population. The study found that:
- Dupixent was both safe and well-tolerated. However, some adverse reactions did occur. These included diarrhea, nausea, rashes, headaches, and COVID-19 infection.
- More patients receiving Dupixent achieved histological remission than those receiving a placebo.
- In addition to improving symptoms and quality-of-life, Dupixent was also associated with weight gain.
Eosinophilic Esophagitis (EoE): The Basics
Eosinophils are a type of white blood cell that play a role in immune regulation. An accumulation of eosinophils is also a hallmark of allergic diseases. In eosinophilic esophagitis, excess eosinophils collect in the esophagus, causing inflammation. Doctors view this chronic disorder as immune-mediated—potentially a response characterized by immune hypersensitivity. People with eosinophilic esophagitis may experience symptoms such as dysphagia (difficulty swallowing), nausea and vomiting, malnutrition and dehydration, unintended weight loss, recurrent abdominal pain, failure to thrive, appetite loss, and a medical emergency called food impaction. Treating EoE often requires modifying one’s diet to remove items such as fish, eggs, wheat, soy, nuts, and milk.