FDA Grants Priority Review for Dupilumab for Eosinophilic Esophagitis

The Food and Drug Administration (FDA) accepted for Priority Review a supplemental biologics license application for dupilumab (Dupixent) for the treatment of adults and pediatric patients 12 years and older with eosinophilic esophagitis (EoE).

Eosinophilic esophagitis is a progressive, type 2 inflammatory disease that causes damage to the esophagus, and estimates have shown an increasing prevalence of the condition in the past 2 decades.

Dupilumab is the only biologic medicine to show positive, clinically meaningful phase 3 results in adults and adolescents with EoE. Currently, there are no approved treatments for the underlying drivers of the disease.

In 2020, dupilumab was granted Breakthrough Therapy designation by the FDA for the treatment of patients 12 years and older with EoE, and the recent sBLA was supported by 2 phase 3 trials that evaluated the efficacy of dupilumab in 300 mg weekly in this patient population.

Data from those trials indicated that dupilumab significantly improved the signs and symptoms of EoE in 24 weeks, with nearly 10 times as many patients treated with dupilumab achieving histological disease remission.

Additionally, a significant decrease in symptoms of dysphagia was observed in patients treated with dupilumab.

“The safety was good in these trials, it's well tolerated; there were really no new types of safety signals that were seen in the program that hadn't been previously reported in the phase 2 data or in the other clinical experience with the medications,” said Evan Dellon, MD, MPH, University of Northern Carolina School of Medicine in a recent interview on the findings. “So I think we’re waiting to see how it looks longer term, and then starting to think about where it's may be able to be used.”

The target action date for the FDA decision is August 3, 2022.