Sun Sentinel Palm Beach Edition
Health experts back treatment for kids with peanut allergy
WASHINGTON — Government experts on Friday backed an experimental treatment for children with peanut allergies that could become the first federally approved option for preventing life-threatening reactions.
The treatment is daily capsules of peanut powder that gradually help children build up a tolerance.
The outside panel of advisers to the Food and Drug Administration voted overwhelmingly in favor of the treatment from Aimmune Therapeutics. The nonbinding vote amounts to an endorsement for approval. The FDA is expected to make a decision by January.
The panelists said the medication was an important option for parents and children dealing with peanut allergies. However, several also had concerns because the pill has to be taken continuously to maintain its effect.
An estimated 1.6 million children and teenagers in the U.S. would be eligible for the medication, to be sold as Palforzia, which is intended for ages 4 to 17.
After one year, about 66% of study participants who took the pills could tolerate the equivalent of three to four peanuts, compared to just 4% of patients who received a dummy treatment.
At the beginning of the study, most participants could not tolerate even a minuscule amount of peanuts.
But the benefits of the treatment came with risks. More than 9% of patients taking the pills reported severe allergic reactions, more than twice the number in the placebo group. And 11% of patients dropped out of the company’s study due to side effects.