01.12.2020 | Immunotherapy and Immunomodulators ( B Vickery, Section Editor) | Ausgabe 12/2020
Oral Immunotherapy for Food Allergy—a US Regulatory Perspective
- Zeitschrift:
- Current Allergy and Asthma Reports > Ausgabe 12/2020
Wichtige Hinweise
This article is part of the Topical Collection on Immunotherapy and Immunomodulators
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Abstract
The recent approval of Palforzia for treatment of peanut allergy by the US Food and Drug Administration (USFDA) predicts that additional products for oral immunotherapy (OIT) are on the horizon. In this article, the authors review the legal framework by which the USFDA regulates products for OIT of food allergy and the clinical data that demonstrated that the safety and effectiveness profile of Palforzia supported approval and conclude with a discussion of oral food challenge (OFC) as a clinical endpoint to demonstrate safety and effectiveness of OIT products.
