The first-ever drug regimen to blunt acute peanut allergies in children should be approved, experts told a Food and Drug Administration committee on Friday, because the therapy has the potential to reduce the risk of life-threatening reactions and to improve patients’ lives.
The new drug, called Palforzia and made by Aimmune Therapeutics, is an oral immunotherapy regimen that aims to reduce sensitivity to peanut allergens. It gradually exposes children to small amounts of peanut protein over the course of six months, until they can safely eat the equivalent of two peanuts.
But the treatment does not work for everyone, and is accompanied by side effects, including severe allergic reactions to the peanut exposure. Twenty percent of the children in the trial who received the treatment withdrew because of adverse events; 14 percent had severe allergic reactions that required treatment with epinephrine, compared with only 6.5 percent who received a placebo.
The regimen begins with trace amounts of the protein that are carefully measured and increased incrementally under medical supervision as tolerance develops.
The goal is not to cure the allergy, but to reduce the risk that an accidental exposure to a small amount of peanut will trigger a life-threatening reaction. It might also relieve some of the fear and anxiety that some people feel about the possibility of experiencing the effects of a severe peanut allergy.
“This is one of the most important unmet needs of medicine,” said Dr. James R. Baker Jr., director of the Mary H. Weiser Food Allergy Center at University of Michigan, who spoke at