FDA approves Palforzia to treat peanut allergy.- Aimmune Therapeutics

Aimmune Therapeutics, Inc. announced that the FDA approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. Palforzia is the first approved treatment for patients with peanut allergy. It 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. Palforzia is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. Palforzia is available only through a Risk Evaluation and Mitigation Strategy (REMS). Requirements of the REMS include: the prescribing physician and patient must be enrolled in the REMS prior to initiation of treatment; the initial dose escalation and the first dose of each up-dosing level must be administered in a certified healthcare setting; epinephrine must always be immediately available to patients; and pharmacies/distributors must be certified with the REMS and dispense Palforzia only to certified healthcare settings or to patients who are enrolled in the REMS. Consistent with approved immunotherapies indicated to treat allergic conditions, the Prescribing Information for Palforzia contains a boxed warning. Comment; Not only is Palforzia the first approved therapy for peanut allergy, but it is the first approved therapy for any food allergy. Comment; Peanut allergy is one of the most common food allergies in the world, affecting more than 1.6 million children and teens in the United States alone. It can be a chronic and life-long condition, and reactions to peanut can range from mild to potentially life-threatening, with one in five peanut-allergic patients visiting emergency rooms each year due to accidental exposures.