FDA approves Palforzia for peanut allergies

The US Food and Drug Administration (FDA) approved Aimmune Therapeutics’ Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) on January 31, 2020.¹ The drug is the first ever to treat peanut allergies in children aged 4 to 17 years. However, children will still need to avoid peanuts in their diet after treatment.

The treatment plan with Palforzia includes 3 distinct phases: initial dose escalation, up-dosing, and maintenance. Initial dose escalation takes place in a single day. The up-dosing phase occurs over several months and includes 11 levels of increasing dosage. Both occur under the supervision of a health care professional in a health care setting in case a severe allergic reaction occurs. Initial dose escalation and the initial dose for up-dosing carry the highest risk of anaphylaxis, but it can occur at any point during the course of therapy.

Following completion of the 2 phases, the child will begin a daily maintenance dose at home. During the maintenance period, parents need to be counseled on having injectable epinephrine available for immediate use as well as how to recognize anaphylaxis and the need for continued dietary peanut avoidance.

The drug is a powder and comes in color-coded capsules for the first 2 phases and in a sachet for the maintenance doses. The powder is meant to be mixed with some semisolid food, such as applesauce or yogurt.

Safety and efficacy proven by studies

Palforzia efficacy was supported by a randomized, double-blind, placebo-controlled study conducted in the United States, Europe, and Canada, which included roughly 500 participants who were allergic to peanuts. The participants were given an oral challenge of a single 600-mg dose of peanut protein, which is twice the daily maintenance dose of Palforzia, followed by 6 months of maintenance treatment of the drug. A total of 67.2% of Palforzia recipients tolerated the challenge versus only 4.0% of participants in the placebo trial.

Two double-blind, placebo-controlled studies that included 700 participants with a peanut allergy were used to assess the safety of Palforzia. Common adverse effects included tingling in the mouth, cough, runny nose, abdominal pain, throat irritation, tightness, itching (including in the mouth and ears), hives, wheezing and shortness of breath, vomiting, nausea, and anaphylaxis. Children with uncontrolled asthma should not be given the therapy. Additionally, because of the risk of anaphylaxis, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) to ensure safe use of the drug.

The FDA cautions that Palforzia reduces the risk of adverse reactions due to inadvertent exposure to peanuts and cannot be used for the emergency treatment of allergic reactions including anaphylaxis. 

According to the manufacturer, the list price for Palforzia will be $890 a month.

References:

1. US Food and Drug Administration. FDA approves first drug for treatment of peanut allergy for children [news release]. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treatment-peanut-allergy-children. Published January 31, 2020. Accessed February 3, 2020.