A few months after the FDA announced a major step toward the eventual approval of a peanut allergy treatment, the big day has finally arrived. Aimmune Therapeutics has announced that its Palforzia peanut allergy treatment has received FDA approval for patients ages four through 17. Before you get too excited, though, take note: this treatment is meant to help protect allergy sufferers who are accidentally exposed to peanuts. It doesn’t get rid of the allergy.
Peanut allergies are often severe and can be deadly, prompting many schools and other public destinations to entirely ban these nuts from their menus. Unfortunately, there aren’t yet any treatments that are able to eliminate this allergy in sufferers; Palforzia, however, may help reduce the severity of allergic reactions in kids and teens.
According to Aimmune Therapeutics, Palforzia is an oral immunotherapy; the initial dose can be given between ages four and 17 with an escalation of the therapy continuing beyond that. The company points out that this is the first therapy to get approval for any food allergy, making it a milestone treatment for the industry.
Palforzia was the subject of a large clinical trial involving more than 1,200 patients and family members, according to the pharmaceutical company. The therapy works by initially exposing the patient to a very small quantity of the allergenic proteins, then slowly increasing the amounts of this exposure over time. Palforzia 0.5mg is the equivalent of 1/600th of a single peanut, according to Aimmune; the dosages range up to 300mg.
Getting the treatment isn’t quite as simple as popping into the local pharmacy, however. Aimmune explains that Palforzia is made available through REMS, which means that the initial dose and each escalation dose has to be given by a doctor in a healthcare setting where epinephrine is available in case an allergic reaction occurs.