FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] for Use in Individuals Ages 1 through 3 Years With a Confirmed Diagnosis of Peanut Allergy
July 26, 2024 -- Today, the FDA approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to include initiation of treatment, up-dosing and maintenance in individuals ages 1 through 3 years with a confirmed diagnosis of peanut allergy to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.
Palforzia has been approved since January 2020 for initiation of treatment in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy with up-dosing and maintenance in individuals 4 years of age and older.
Those who take Palforzia must continue to avoid peanuts in their diets.
A Risk Evaluation and Mitigation Strategy (REMS) is in place for Palforzia to mitigate the risk of anaphylaxis associated with Palforzia, which includes elements to assure safe use, which includes elements to assure safe use.
Source: FDA
Posted: July 2024
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- FDA Approves Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] as First Treatment for Peanut Allergy - January 31, 2020
- FDA Allergenic Products Advisory Committee Votes to Support the Use of Aimmune’s Palforzia (AR101) for Peanut Allergy - September 13, 2019
- Aimmune Therapeutics Submits BLA to FDA for AR101 for the Treatment of Peanut Allergy in Children and Adolescents Ages 4–17 - December 21, 2018
Palforzia (Peanut (Arachis hypogaea) Allergen Powder-dnfp) FDA Approval History
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