FDA approves first drug for eosinophilic esophagitis

Eosinophilic esophagitis (EoE) is a chronic disease requiring long-term treatment for both induction and maintenance of response. For decades, however, Food and Drug Administration–approved therapies for EoE have not been available. Dupilumab is the first drug to receive FDA approval to treat EoE. This human monoclonal antibody directed against the interleukin (IL)4 receptor–alpha component of the type 2 receptor inhibits signaling of IL4 and IL13. Dupilumab has shown efficacy in similar diseases, such as atopic dermatitis and eosinophilic asthma. In 2017 dupilumab was granted Orphan Drug designation for the potential treatment of EoE and in 2020 the FDA granted Breakthrough Therapy designation for EoE. Recent data from the phase 3 trial of dupilumab 300 mg weekly enrolling patients aged 12 years and older demonstrated a significantly greater reduction in disease symptoms, normalization of esophageal eosinophilia, and reduction in endoscopic findings by week 24 compared with placebo.

The highly anticipated approval of dupilumab marks a paradigm shift toward biologic medications for treatment of EoE when historical treatments have relied on proton pump–inhibitor therapy or topical swallowed steroids. As we await updates about availability and access of dupilumab for our patients, we can rest assured that a highly efficacious treatment is now approved and will fill an important treatment gap in EoE, particularly for patients not deriving adequate response with traditionally used strategies. With multiple clinical trials underway, this milestone likely represents the beginning of additional effective therapies (nonbiologic and biologic) that will be available for EoE.

Rena Yadlapati, MD, MSHS, FACG, is associate professor of clinical medicine in the division of gastroenterology at the University of California, San Diego, medical director of the UCSD Center for Esophageal Diseases, and director of the GI Motility Lab. She has no relevant conflicts of interest.