White Paper AGA: Drug Development for Eosinophilic Esophagitis

Ikuo Hirano, Stuart Spechler, Glenn Furuta, Evan S. Dellon

Research output: Contribution to journalArticle

13 Scopus citations

Abstract

Since first characterized in 2 small case series in the early 1990s, eosinophilic esophagitis (EoE) has emerged as a commonly identified cause of esophageal symptoms in children and adults.1,2 Although several highly effectively dietary, pharmacologic, and endoscopic therapies have been reported, none is currently approved by either the US Food and Drug Administration (FDA) or European regulatory authorities. Evolving diagnostic criteria have challenged drug development, in particular the recognition of complex interactions with the most prevalent esophageal disorder, gastroesophageal reflux disease (GERD). Heterogeneity in the clinical presentations of affected children and adults has created difficulties with uniform inclusion criteria and the development of disease-specific, patient-reported outcome (PRO) instruments. Furthermore, controversies regarding the appropriate therapeutic endpoints of EoE have impeded the design of clinical trials. Despite these obstacles, collaborative efforts by investigators, industry, the FDA, and patient advocacy groups have resulted in substantial progress in drug development in EoE over the past 2 decades.3 The purpose of this article is to summarize discussions on EoE based on the 2016 Drug Development Conference sponsored by the Center for Diagnostics and Therapeutics of the American Gastroenterological Association.

Original languageEnglish (US)
Pages (from-to)1173-1183
Number of pages11
JournalClinical Gastroenterology and Hepatology
Volume15
Issue number8
DOIs
Publication statusPublished - Aug 1 2017

    Fingerprint

Keywords

  • Dysphagia
  • Eosinophilic Esophagitis
  • Esophageal Stricture
  • Esophagitis
  • Food Allergy
  • Gastroesophageal Reflux Disease

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this