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Palforzia FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved January 31, 2020)
Brand name: Palforzia
Generic name: Peanut (Arachis hypogaea) Allergen Powder-dnfp
Previous Name: AR101
Company: Aimmune Therapeutics, Inc.
Treatment for: Peanut Allergy

Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) is an oral immunotherapy indicated to help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.

  • Palforzia is a treatment for people who are allergic to peanuts.
  • Palforzia may be started in patients aged 4 through 17 years of age. Patients who turn 18 years of age during treatment should continue taking Palforzia unless otherwise instructed by their doctor.
  • Palforzia does NOT treat allergic reactions and should not be given during an allergic reaction.
  • Patients must maintain a strict peanut-free diet while taking Palforzia.
  • Because of the risk of anaphylaxis, Palforzia is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Palforzia REMS.

Development timeline for Palforzia

Jan 31, 2020Approval FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] as First Treatment for Peanut Allergy
Sep 13, 2019FDA Allergenic Products Advisory Committee Votes to Support the Use of Aimmune’s Palforzia (AR101) for Peanut Allergy
Dec 21, 2018Aimmune Therapeutics Submits BLA to FDA for AR101 for the Treatment of Peanut Allergy in Children and Adolescents Ages 4–17
Dec 19, 2018Aimmune Therapeutics Initiates Phase 3 POSEIDON Trial for Treatment of Peanut Allergy in 1–3-Year-Old Children
Nov 18, 2018Landmark PALISADE Trial of AR101 Published in New England Journal of Medicine
Feb 20, 2018Aimmune Therapeutics’ Pivotal Phase 3 PALISADE Trial of AR101 Meets Primary Endpoint in Patients With Peanut Allergy
Feb  4, 2018Aimmune Therapeutics Presents Results From the Positive, Pivotal Phase 3 PALISADE Trial of AR101 for Peanut Allergy

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.