PALFORZIA
STN: 125696
Proper Name: Peanut (Arachis hypogaea) Allergen Powder
Tradename: PALFORZIA
Manufacturer: Aimmune Therapeutics, Inc.
Indication:
- PALFORZIA is an oral immunotherapy indicated for the mitigation 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 Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older.
- PALFORZIA is to be used in conjunction with a peanut-avoidant diet.
Product Information
- Package Insert - PALFORZIA
- Medication Guide - PALFORZIA
- Demographic Subgroup Information - PALFORZIA (Peanut (Arachis hypogaea) Allergen Powder-dnfp)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- March 3, 2023 Approval Letter - PALFORZIA
- January 31, 2020 Summary Basis for Regulatory Action - PALFORZIA
- January 31, 2020 Approval Letter - PALFORZIA
- Approved Risk Evaluation and Mitigation Strategies (REMS) - PALFORZIA
- Statistical Review - PALFORZIA
- Approval History, Letters, Reviews, and Related Documents - PALFORZIA