Impressions and aspirations from the FDA GREAT VI Workshop on Eosinophilic Gastrointestinal Disorders Beyond Eosinophilic Esophagitis and Perspectives for Progress in the Field.
J Allergy Clin Immunol
; 149(3): 844-853, 2022 03.
Article
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| MEDLINE
| ID: mdl-34953790
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.
Palabras clave
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
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Enteritis
/
Esofagitis Eosinofílica
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Gastritis
Límite:
Adult
/
Child
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Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
J Allergy Clin Immunol
Año:
2022
Tipo del documento:
Article