Affordable Access

Access to the full text

Oral Immunotherapy for Food Allergy—a US Regulatory Perspective

Authors
  • Hise, Kathleen1, 1
  • Rabin, Ronald L.1, 1
  • 1 US Food and Drug Administration, Silver Spring, MD, USA , Silver Spring (United States)
Type
Published Article
Journal
Current Allergy and Asthma Reports
Publisher
Springer-Verlag
Publication Date
Oct 15, 2020
Volume
20
Issue
12
Identifiers
DOI: 10.1007/s11882-020-00973-x
Source
Springer Nature
Keywords
License
Yellow

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.

Report this publication

Statistics

Seen <100 times