The US FDA has approved Palforzia (Aimmune Therapeutics) to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts in children ages 4 through 17 years old.
Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] may be initiated in kids 4-17 with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older, according to the FDA, which noted that those who take Palforzia must continue to avoid peanuts in their diets.
Palforzia is a powder that is manufactured from peanuts and packaged in pull-apart color-coded capsules for Dose Escalation and Up-Dosing, and in a sachet for maintenance treatment. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food (such as applesauce, yogurt, or pudding) that the patient then consumes.
Treatment with Palforzia consists of three phases:
- Initial Dose Escalation: The Initial Dose Escalation phase is given on a single day.
- Up-Dosing: the Up-Dosing phase consists of 11 increasing dose levels and occurs over several months. Initial Dose Escalation, and the first dose of each Up-Dosing level, are administered under supervision of a healthcare professional in a healthcare setting with the ability to manage potentially severe allergic reactions, including anaphylaxis. While anaphylaxis can occur at any time during Palforzia therapy, patients are at highest risk during and after the Initial Dose Escalation and the first dose of each Up-Dosing level. During Up-Dosing, if the patient tolerates the first dose of an increased dose level, the patient may continue that dose level daily at home.
- Maintenance: after a patient completes all Up-Dosing levels, they may begin the daily maintenance dose. Patients who experience certain allergic reactions due to Palforzia may need to discontinue treatment or have their dosing schedule modified.
“Peanut allergy affects approximately 1 million children in the US and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. “Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.”
Palforzia cannot be used for the emergency treatment of allergic reactions, including anaphylaxis, and should not be administered to those with uncontrolled asthma, the FDA noted.
To mitigate the risk of anaphylaxis associated with Palforzia, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) with this approval, which includes elements to assure safe use.
Palforzia will only be available through specially certified healthcare providers, healthcare settings, and pharmacies to patients who are enrolled in the REMS program.
The FDA is requiring that healthcare providers who prescribe Palforzia and healthcare settings that dispense and administer Palforzia are educated on the risk of anaphylaxis associated with its use.
In addition, the Initial Dose Escalation phase and first dose of each Up-Dosing level must only be administered to patients in a certified healthcare setting equipped to monitor patients and to identify and manage anaphylaxis. Patients or their parents or caregivers must also be counseled on the need for the patients to have injectable epinephrine available for immediate use at all times, the need for continued dietary peanut avoidance, and how to recognize the signs and symptoms of anaphylaxis.