FDA experts recommend new drug to reduce sensitivity to peanut allergens

A Food and Drug Administration (FDA) panel has on Friday recommended approval of the first-ever drug to treat life-threatening peanut allergies in children, a condition that confounds and frightens families across the country.
 
The recommendation all but assures the agency will approve the drug, called Palforzia and made by Aimmune Therapeutics. The FDA typically follows the advice of its expert advisory committees.
 
Some panel members expressed reservations about the safety of the drug, since patients receiving treatment experienced more allergic reactions than those given a placebo. There is also little long-term safety data about a treatment that may be lifelong, the critics noted.

 

The drug’s goal is not to cure the allergy, but to reduce the risk that an accidental exposure to small amounts of peanut will set off a life-threatening reaction. It might also relieve some of the fear and anxiety many families experience as they struggle to cope with a child’s severe peanut allergy.
 
“This is one of the most important unmet needs of medicine,” James R Baker Jr, director of the Mary H. Weiser Food Allergy Center at University of Michigan, told the agency’s advisory committee. He was paid by Aimmune.
 
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, adding that even scrupulous efforts to prevent exposures fail, resulting in life-threatening medical emergencies.

 
“The quality of life of patients and their caregivers is adversely affected due to fear and anxiety about accidental ingestions,” he added.
 
Allergists who treat children with peanut allergies applauded the decision, though they acknowledged the treatment regimen was demanding and not appropriate for everyone.
 
“Until now, patients with life-threatening peanut allergies had no options but avoidance,” said Sandra Hong, an allergist at the Cleveland Clinic.
 
Still, “it is an exciting step for patients and their families who live in constant worry about coming in contact with even the slightest amount of peanut.”
 
The new drug 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.

 
The treatment is not always effective and it is accompanied by side effects, including severe allergic reactions to the peanut exposure.
 © 2019 The New York Times News Service