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Oral Immunotherapy for Food Allergy—a US Regulatory Perspective

  • Immunotherapy and Immunomodulators ( B Vickery, Section Editor)
  • Published:
Current Allergy and Asthma Reports Aims and scope Submit manuscript

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.

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References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

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Acknowledgments

The authors wish to thank Pamela A. Frischmeyer-Guerrerio M.D. for helpful discussions and careful review of the manuscript.

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Authors and Affiliations

  1. Division of Vaccines and Related Products Applications, US Food and Drug Administration, Silver Spring, MD, USA

    Kathleen Hise

  2. Division of Bacterial, Parasitic, and Allergenic Products, US Food and Drug Administration, Silver Spring, MD, USA

    Ronald L. Rabin

  3. Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

    Kathleen Hise & Ronald L. Rabin

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  1. Kathleen Hise
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  2. Ronald L. Rabin
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Correspondence to Ronald L. Rabin.

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This article is part of the Topical Collection on Immunotherapy and Immunomodulators

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Hise, K., Rabin, R.L. Oral Immunotherapy for Food Allergy—a US Regulatory Perspective. Curr Allergy Asthma Rep 20, 77 (2020). https://doi.org/10.1007/s11882-020-00973-x

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  • DOI: https://doi.org/10.1007/s11882-020-00973-x

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