Palforzia FDA Approval History
Last updated by Judith Stewart, BPharm on July 29, 2024.
FDA Approved: Yes (First approved January 31, 2020)
Brand name: Palforzia
Generic name: Peanut (Arachis hypogaea) Allergen Powder-dnfp
Dosage form: Capsules and Sachets
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 approved for use in patients with a confirmed diagnosis of peanut allergy. Initial treatment may be administered to patients aged 1 through 17 years. Up-dosing and maintenance treatment may be continued in patients 1 year of age and older.
- Palforzia is to be used in conjunction with a peanut-avoidant diet.
- Palforzia is not indicated for the emergency treatment of allergic reactions, including anaphylaxis, and should not be given during an allergic reaction.
- Palforzia powder for oral administration is supplied as capsules or sachets. The capsules should not be swallowed. The powder contained in the capsules or sachets should be emptied onto refrigerated or room temperature semisolid food, then mixed well and consumed.
- 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.
- Warnings and precautions associated with Palforzia include risk of anaphylaxis, eosinophilic esophagitis, and gastrointestinal allergic symptoms. Palforzia should be temporarily withheld if the patient is experiencing an acute asthma exacerbation.
- Common adverse reactions:
- in patients ages 1 through 3 years include cough, sneezing, rhinitis, nasal congestion, throat irritation, wheezing, abdominal pain, vomiting, diarrhea, oral pruritus, oropharyngeal pain, urticaria, rash, pruritis, perioral dermatitis.
- in patients ages 4 through 17 years include abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.
Development timeline for Palforzia
Further information
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