On Friday, the Food and Drug Administration (FDA) experts recommended approval for Palforzia, the first-ever oral drug developed by Aimmune Therapeutics to treat peanut allergies in children, which could be life-threatening.
The agency generally follows the recommendation of its panel of experts. However, some panel experts expressed concerns about the drug’s safety because patients who took the drug had more allergic responses than patients who took a placebo. They noted there is not much long-term data regarding the drug, which may be lifelong.
The experts explained that the goal of Palforzia does not cure peanut allergy but it reduces the risk of accidental exposure to peanuts that may lead to a life-threatening allergic reaction. The drug may also help relieve some anxiety and fear among families who struggle with their children’s peanut allergies.
In the United States, more than 1.2 million children have a peanut allergy, which could cause death from anaphylaxis, an acute biological response that causes low blood pressure, constriction of airways, and shock.
Dr. James Baker, the director of the Mary H. Weiser Food Allergy Center at University of Michigan, told the FDA’s panel members, “This is one of the most important unmet needs of medicine,” noting that the need for the drug among children with peanut allergies and their parents is “enormous.”
He said, “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.”
Parents take conscientious efforts to keep their children from exposures but there are still medical emergencies caused by accidental exposures.
“Families spend incredible efforts, often altering their entire lifestyle to practice avoidance,” added Dr. Baker. “The quality of life of patients and their caregivers is adversely affected due to fear and anxiety about accidental ingestions.”
Palforzia is an oral immuno therapy drug that helps in reducing sensitivity to peanuts. The drug gradually helps children to get exposed to some peanut protein for over six months until they are considered safe to consume at least two peanuts.
The panel experts said the drug is not for everyone with peanut allergies. It comes with a few side effects, including a severe allergic reaction after peanut exposure.
Clinical trials found that at least one in five children had to stop the drug because of the side effects and 14 percent of the participants had a severe allergic reaction.
The FDA said the drug will come with a “black-box” warning that will carry precautions to the risks of peanut exposure. The agency will require Aimmune to “warn patients that they still must avoid peanuts.”