Experts: Peanut allergy drug will protect kids

FDA will decide whether to approve first regimen.

The first drug regimen to blunt acute peanut allergies in children should be approved, experts told a Food and Drug Administration committee last week, because the therapy has the potential to reduce the risk of life-threatening reactions and improve patients’ lives.

What happened

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 safety 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% had severe allergic reactions that required treatment with epinephrine, compared with only 6.5% who received a placebo.

Why it matters

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 James Baker, director of the Mary H. Weiser Food Allergy Center at University of Michigan, who spoke at the advisory committee meeting on behalf of the company. He was compensated for his time.

The demand for treatment among patients and their families is enormous, Baker noted. “Right now the only approved approach to this allergy is to avoid peanuts, and the amount of effort and cost involved in making sure everything your child is exposed to is peanut-free is overwhelming to most families,” he said.

Yet even scrupulous efforts to prevent exposures fail, resulting in life-threatening medical emergencies. “Families spend incredible efforts, often altering their entire lifestyle to practice avoidance,” Baker told the agency’s advisory committee.

“The quality of life of patients and their caregivers is adversely affected due to fear and anxiety about accidental ingestions,” he added.

TONY CENICOLA / THE NEW YORK TIMES “(Treating peanut allergy) is one of the most important unmet needs of medicine,” said James Baker, director of the Mary H. Weiser Food Allergy Center at University of Michigan.