FDA approves first drug for treatment of peanut allergy for children

This new treatment was developed after years of research, much of it spearheaded and completed by Wesley Burks, MD, and Edwin Kim, MD at the UNC School of Medicine.

FDA approves first drug for treatment of peanut allergy for children click to enlarge Wesley Burks, MD, and Edwin Kim, MD

February 3, 2020

The U.S. Food and Drug Administration approved Palforzia to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Treatment with Palforzia may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older. Those who take Palforzia must continue to avoid peanuts in their diets. 

This treatment was developed by the company Aimmune and was studied rigorously during the PALISADE clinical trials, which culminated in 2018. Wesley Burks, MD, Dean of the UNC School of Medicine and CEO of UNC Health Care, was senior author of a paper published in the New England Journal of Medicine, showing the results of the large phase 3 trial that led to FDA approval. Edwin Kim, MD, assistant professor of medicine, was the UNC site principal investigator. He is also investigating other methods to treat peanut and other allergies and has become a leading expert in food allergy research.

Burks and Kim are members of the UNC Children's Research Institute, and both have been instrumental at advancing oral immunotherapy to help kids with peanut allergies. Dr. Burks initiated research on this approach while on faculty at Duke before joining the UNC School of Medicine as chair of the Department of Pediatrics. He was senior author on the first study in 2009 showing the potential efficacy of oral immunotherapy to help kids with peanut allergies.

You can read the FDA's announcement of this treatment's approval here. You can also read a newsletter on the newly approved treatment from the president of the American Academy of Allergy, Asthma & Immunology.

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