Oral Immunotherapy for Food Allergy-a US Regulatory Perspective

被引：12

作者：

Hise, Kathleen ^{[1
,3
]}

Rabin, Ronald L. ^{[2
,3
]}

机构：

[1] US FDA, Div Vaccines & Related Prod Applicat, Silver Spring, MD USA

[2] US FDA, Div Bacterial Parasit & Allergen Prod, Silver Spring, MD 20993 USA

[3] US FDA, Off Vaccines Res & Review, Ctr Biol Evaluat & Res, Silver Spring, MD 20993 USA

来源：

CURRENT ALLERGY AND ASTHMA REPORTS | 2020年 / 20卷 / 12期

关键词：

Food allergy; Oral immunotherapy; Oral food challenge; US Food and Drug Administration; Anaphylaxis;

D O I：

10.1007/s11882-020-00973-x

中图分类号：

R392 [医学免疫学];

学科分类号：

100102 ;

摘要：

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.

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页数：7

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