- Title
- Ascending to new heights for novel therapeutics for eosinophilic esophagitis
- Creator
- Hirano, Ikuo; Dellon, Evan S.; Peterson, Kathryn; Talley, Nicholas J.; Bierdermann, Luc; von Arnim, Ulrike; Savarino, Edoardo V.; Schlag, Christoph; Wershil, Barry K.; Menard-Katcher, Calies; Muir, Amanda B.; Wechsler, Joshua B.; Falk, Gary W.; Chehade, Mirna; Spergel, JM; Atkins, D; Oliva, S; Arva, NC; Guang-Yu, Y; Jensen, ET; Safroneeva, E; Ackerman, S; Gupta, SK; Gonsalves, Nirmala P.; Rothenberg, M; Katzka, D; Pletneva, M; Wright, BL; Hiremath, G; Klion, A; Attwood, S; Bonis, P; Aceves, S; Ghisa, M; Furuta, Glenn T.; Miehlke, S; Vanuytsel, T; Woodland, G; Thomas, G; Kuang, FL; Bredenoord, Albert J.; Assessment of Clinical endpoints in Eosinophilic esophagitis for Novel Therapeutics (ASCENT) working group,; Straumann, Alex; Schoepfer, Alain; Chang, Joy W.
- Relation
- Gastroenterology Vol. 166, Issue 1, p. 1-10
- Publisher Link
- http://dx.doi.org/10.1053/j.gastro.2023.09.004
- Publisher
- Elsevier
- Resource Type
- journal article
- Date
- 2024
- Description
- Since the initial descriptions of eosinophilic esophagitis (EoE) in the early 1990s, great progress has been made in refinement of diagnostic criteria and clinical trial design, collaboration with the pharmaceutical industry in the development of therapeutics, identification of novel therapeutic targets, engagement with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) regarding regulatory pathways for drug approval, dissemination of educational and guidance documents supported by professional academic allergy/immunology and gastroenterology societies, development and validation of clinical outcomes, investigative efforts including a National Institutes of Health multi-center grant (Consortium of Eosinophilic Gastrointestinal Disease Researchers), and close collaboration with patient advocacy groups.1, 2, 3, 4, 5, 6, 7, 8 These efforts resulted in approvals of a budesonide tablet formulation by the EMA in 2018 and a monoclonal antibody for interleukin-4Rα (dupilumab) in 2022–2023 by both the FDA and the EMA.9,10.
- Subject
- eosinophilic; esophagitis; pharmaceutical industry; therapeutics
- Identifier
- http://hdl.handle.net/1959.13/1494318
- Identifier
- uon:53764
- Identifier
- ISSN:0016-5085
- Language
- eng
- Reviewed
- Hits: 11391
- Visitors: 11086
- Downloads: 0
| Thumbnail | File | Description | Size | Format |
|---|