An oral remedy that aims to reduce the incidence and severity of allergic reactions in people age 4-17 will be considered Friday at a Food and Drug Administration (FDA) hearing.
Dr. James R. Baker, director of U-M's Mary H. Weiser Food Allergy Center, will be among the experts testifying to federal officials about the safety and efficacy of the treatment. Known as Peanut Allergen Powder and manufactured by Aimmune Therapeutics, Inc., the drug has been shown in clinical trials to moderate symptoms in many subjects under age 18 who were exposed to peanut protein. One of the latter trials tested the treatment on individuals at 66 sites throughout North America and Europe.
The FDA session is scheduled to run from 8:30 a.m. to 4:30 p.m. on Friday, September 13. Live-streaming is expected to be available at https://collaboration.fda.gov/apac091319/
Dr. Baker will testify in conjunction with other medical experts in the food allergy field, along with officials from Aimmune Therapeutics.
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.