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# FDA Approves Peanut Allergy Drug
- URL: https://www.fdaweb.com/fda-approves-peanut-allergy-drug/
- Published: 2020-01-31T12:00:00.000Z
- Updated: 2026-09-14T16:01:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145988

FDA has approved Aimmune Therapeutics’ Palforzia \[peanut (*Arachis hypogaea*) allergen powder-dnfp\] for treating allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. An [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treatment-peanut-allergy-children?ref=fdaweb.com) says Palforzia may be administered in individuals aged four through 17 years, and that patients must continue to avoid peanuts in their diets.

Treatment involves three phases — an initial dose escalation, up-dosing, and maintenance, the agency says. “While anaphylaxis can occur at any time during Palforzia therapy, patients are at highest risk during and after the initial dose escalation and the first dose of each up-dosing level,” it warns.

Approval is based on data involving 500 peanut-allergic individuals. “The results showed that 67.2% of Palforzia recipients tolerated a 600 mg dose of peanut protein in the challenge, compared to 4.0% of placebo recipients,” FDA says. Common side effects were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath and anaphylaxis, it says, adding that the drug should not be administered to those with uncontrolled asthma.