In its coverage of the FDA hearing, the New York Times highlighted the remarks by James R. Baker, MD, director of the MHWFAC.
The demand for treatment among patients and their families is enormous, Dr. 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.
Following the hearing, the panel recommended approval of the treatment, Palforzia, which was developed by Aimmune Therapeutics. Palforzia does not cure peanut allergy, but it mitigates reaction to accidental exposure in many patients.
The University of Michigan was among the research sites that participated in the trial, whose full findings were published in the New England Journal of Medicine in November 2018. Children in the yearlong trial who developed peanut tolerance after gradual exposure to carefully measured amounts of peanut protein that increased incrementally under medical supervision. Two-thirds of the 372 children who received the treatment were able to ingest 600 milligrams or more of peanut protein (about two peanuts) without an allergic reaction. They underwent six months of treatment followed by six months of maintenance therapy.
By contrast, only 4 percent of the 124 children who had been given a placebo powder could consume the same amount of peanut without a reaction. Roughly 4 percent of children receiving the active drug experienced severe side effects, and 20 percent of the children in the active treatment group withdrew from the study.
Read the entire New York Times article here.