FDA guidance for eosinophilic esophagitis treatment trials

The US Food and Drug Administration is announcing the finalization of a guidance for industry titled, “ Eosinophilic Esophagitis:  Developing Drugs for Treatment.”

Eosinophilic Esophagitis (EoE) is a chronic immune or antigen-mediated disease characterized by white blood cell (eosinophil-predominant) inflammation of the esophagus. Left untreated, EoE leads to difficulty swallowing food, esophageal narrowing, and food getting stuck in the esophagus.

Although there has been an increase in the number of development programs for the treatment of eosinophilic esophagitis (EoE), there are currently no FDA approved therapies for the treatment of EoE. The final guidance promotes successful development of drugs and therapeutic biologics for the treatment of patients with EoE by providing clarity on FDA expectations and recommendations. Specifically, the guidance provides the FDA’s current thinking regarding clinical trials and development programs for EoE drugs including recommendations for the necessary attributes of patients for enrollment, trial designs, efficacy considerations, safety assessments and pediatric considerations.