AR101, to be sold under the name Palforzia, mitigates allergic reactions that may occur with accidental exposure to peanuts.
It’s the first oral drug on the market to offer relief from peanut allergy symptoms for individuals who previously had to avoid all contact with peanuts in any form.
The drug uses oral immunotherapy, giving tiny but increasing amounts of peanut protein over six months under medical supervision.
Users must then take a daily dose so they can tolerate accidental exposure to peanuts.
Those who take Palforzia must continue to avoid peanuts in their diets.
Peanut allergy affects approximately 1 million children in the U.S., and only 1 out of 5 of them will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions. pic.twitter.com/3T6h0VC5Rq
— Dr. Stephen M. Hahn (@SteveFDA) January 31, 2020
According to the FDA, the effectiveness of Palforzia is supported by a study conducted in the US, Canada and Europe in around 500 peanut-allergic individuals.
The drug’s safety was assessed in studies of approximately 700 peanut-allergic individuals.
Peanut allergies affect around 1 million American children, with only 1 out of 5 outgrowing their allergy.
They are the leading cause of death for food-induced allergic reactions in the US.
