On Friday, United States health experts backed an experimental treatment for kids who are allergic to peanuts. This treatment could become the first federally approved method for hindering life-threatening allergic reactions.
The treatment would entail a daily dose of peanut powder in a capsule to help build up tolerance. Panelists agreed that this would be a vital option for parents to help their children but are also concerned due to the fact that the capsule needs to be taken daily repeatedly to maintain the effect.
“What I would say about Palforzia, once approved, is it does exactly what other immunotherapy does. You start at low doses, slowly escalating, charging up the immune system with the same thing you’re trying to mount an immune response against,” Aimmune CEO Jayson Dallas told FierceBiotech.
The panel of advisors to the FDA voted strongly in favor of this treatment by Aimmune Therapeutics. The FDA is expected to make their final decision by January.
If approved, the treatment will be sold under the name ‘Palforzia’ to children 4 to 17 years old. Over 1.5 million children would be eligible for the remedy.
1 in 4 children with peanut allergies are sent to the E.R. every year, due to the fact that the most common treatment is to rigorously observe what those children eat.
Parents at the hearing encourage approval of the treatment sharing their struggles with watching their child’s diet and avoiding public and transportation due to possible peanut debris.
“These are constant and real fears with extreme consequences,” said Cathy Heald of Dallas, whose 12-year-old son Charlie took part in a study of the treatment.
Heald says the experimental treatment allowed her son to travel overseas alone for the first time ever.
“The peace of mind this treatment brings is invaluable” said Heald, whose trip to the meeting was paid by Aimmune.
After a year, around 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 placebo treatment. At the beginning of the study, most participants could not tolerate even a minuscule amount of peanuts.
Though, there were also downsides to the study. Over 9% of patients taking the medicine reported serious allergic reactions. 11% of patients dropped out of the study due to harsh 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.
Aimmune Therapeutics expects the first six months of treatment to cost from $5,000 to $10,000 and $300 to $400 each month after that.
The company is also working on treatments for other food allergies, including eggs and tree nuts. Aimmune does not currently have any products on the market.
Click here for more information on Aimmune Therapeutics and their Peanut Allergy Therapy treatment.