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Palforzia Approval Status

FDA Approved: No
Brand name: Palforzia
Generic name: peanut immunotherapy
Previous Name: AR101
Company: Aimmune Therapeutics, Inc.
Treatment for: Peanut Allergy

Palforzia (AR101) is an investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.

Development Status and FDA Approval Process for Palforzia

DateArticle
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

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