Palforzia is a powder that reduces allergic reactions, including anaphylaxis, that may occur following exposure to peanuts.
Can be administered to children ages 4 through 17 with a confirmed diagnosis of peanut allergy.
Children taking Palforzia must continue to avoid consuming peanuts.
In a randomized, double-blind, placebo-controlled study comprised of approximately 500 peanut-allergic individuals.
67.2% of Palforzia recipients tolerated a 600 mg dose of peanut protein, juxtaposed to 4% of recipients in the placebo arm.
The most common side effects of Palforzia were:
Abdominal pain
Vomiting
Nausea
Tingling in the mouth
Itching
Cough
Runny nose
Throat irritation and tightness
Hives
Wheezing and shortness of breath
Anaphylaxis
It should not be administered to patients with uncontrolled asthma.
Treatment with Palforzia, which is manufactured from peanuts and packaged in capsules.
It is indicated for use in children 4-17 years old and maintenance can be continued to age 18.
Management consists of three phases: Initial Dose Escalation, Up-Dosing, and Maintenance.
The Initial Dose Escalation phase is administered on a single day.
The Up-Dosing phase includes 11 increasing dose levels and occurs over several months.
Administration under supervision of a healthcare professional in a healthcare setting with the ability to manage potentially severe allergic reactions, including anaphylaxis.
To allay the risk of anaphylaxis associated with Palforzia, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS).
Peanut allergy affects approximately 1 million children in the U.S. and only 1 out of 5 of these children will outgrow their allergy.