Impressions and aspirations from the FDA GREAT VI Workshop on Eosinophilic Gastrointestinal Disorders Beyond Eosinophilic Esophagitis and Perspectives for Progress in the Field

Marc E. Rothenberg*, Shawna K.B. Hottinger, Nirmala Gonsalves, Glenn T. Furuta, Margaret H. Collins, Nicholas J. Talley, Kathryn Peterson, Calies Menard-Katcher, Macie Smith, Ikuo Hirano, Robert M. Genta, Mirna Chehade, Sandeep K. Gupta, Jonathan M. Spergel, Seema S. Aceves, Evan S. Dellon

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

The US Food and Drug Administration hosted a workshop on July 21, 2021, to discuss the disease characteristics, natural history, and end points to assess treatment benefit in patients with eosinophilic gastrointestinal disorders (EGIDs) beyond eosinophilic esophagitis (EoE). Notably, EGIDs beyond EoE, such as eosinophilic gastritis, eosinophilic enteritis, and eosinophilic colitis, herein referred to as non-EoE EGIDs, are understudied relative to EoE. This workshop provided a forum for open discussion among stakeholders—medical professionals (including their societies and research groups), Food and Drug Administration representatives, an industry representative, and a patient representative—to facilitate drug development. Experts in many disciplines related to EGIDs, including allergy, immunology, epidemiology, gastroenterology, and pathology, and both adult and pediatric clinicians contributed. Herein, we discuss some of the insights of the material presented at the meeting and present perspectives on moving the field forward toward drug approval.

Original languageEnglish (US)
Pages (from-to)844-853
Number of pages10
JournalJournal of Allergy and Clinical Immunology
Volume149
Issue number3
DOIs
StatePublished - Mar 2022

Keywords

  • Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR)
  • Food and Drug Administration (FDA)
  • diagnosis
  • eosinophilic colitis
  • eosinophilic duodenitis
  • eosinophilic enteritis
  • eosinophilic gastritis
  • eosinophilic gastroenteritis
  • eosinophilic gastrointestinal disorder
  • food allergy
  • treatment

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

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