An advisory committee for the Food and Drug Administration voted Friday to recommend a peanut allergy treatment for FDA approval.
The drug, called Palforzia and made by Aimmune Therapeutics, would be the first FDA-approved drug for treating food allergies.
Palforzia is a type of oral immunotherapy. The treatment involves exposing children with peanut allergies to increasing doses of peanut protein, in order to build up tolerance over time. The goal of the treatment is not to get rid of a peanut allergy entirely, but to reduce a person’s risk of severe reactions in case of accidental exposures.
The vote from advisory committee does not mean the drug is approved, however most drugs recommended by advisory committee do go on to win FDA approval. The FDA will make its decision in the coming months.
“From a science standpoint, this is a breakthrough,” said Dr. Bruce Lanser, a pediatric allergist and immunologist and director of the pediatric food allergy program at National Jewish Health in Denver. Lanser ran one arm of the clinical trials on the treatment.
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Erin Sorce, of Denver, agreed. Her 13-year-old son Colton participated in a clinical trial for separate but similar peanut allergy treatment.
“I feel like this would be revolutionary,” Sorce said. “The thought of kids having access to something like that brings tears to my eyes.”
The panelists said the medication was an important option for parents and children dealing with peanut allergies. However, several also said they 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, which is intended for ages 4 to 17.
Peanut allergy is the most common food allergy in the country and the standard treatment involves strictly monitoring what children eat. That approach doesn't always work and accidental exposure is common, sending 1 in 4 children with peanut allergies to the emergency room every year.
After one year, about 66 percent of study participants who took the pills could tolerate the equivalent of three to four peanuts, compared to just 4 percent 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 percent of patients taking the pills reported severe allergic reactions, more than twice the number in the placebo group. And 11 percent of patients dropped out of the company's study due to side effects.
"The effectiveness of the treatment has, in fact, not been demonstrated," said Dr. John Kelso, of Scripps Clinic in San Diego, who voted against the treatment.
The California-based company has previously said it expects the first six months of treatment to cost $5,000 to $10,000 and $300 to $400 a month after that. The company told NBC News that it doesn't expect to establish a price for the treatment until after the potential FDA approval.
"Aimmune’s overall goal will be to ensure that affordability is not an obstacle for any eligible patients regardless of insurance or financial status," a spokesperson for the company said. "We will work closely with payers to achieve our goal of achieving access for eligible patients."
Aimmune is pursuing other treatments for common food allergies, including eggs. The company does not yet have any products on the market.
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