The advisory panel will make its recommendation after discussing safety and efficacy of the drug currently known as AR101. The panel will also hear from researchers, participants from AR101 clinical trials, and others.
The FDA granted manufacturer Aimmune Therapeutics fast track status in 2014 for clinical trials of AR101, and breakthrough therapy status in 2015. After conducting a clinical trial with 551 peanut allergy sufferers, the company reported that about two-thirds of the group could tolerate small amounts of peanut protein after a year of AR101 therapy. If approved, the treatment would be used to reduce life-threatening allergic reactions caused by accidental peanut exposure.
AR101 is designed to be given in increasing doses to gradually desensitize allergic patients to peanut allergies, according to Aimmune documents.
Aimmune has filed a proposed trade name for the new pill: "Palforzia."
Understanding Peanut Allergies
Peanut allergies affect between .6% and 1.3% of Americans, writes Syed Mustafa, MD, an immunologist who has performed research on peanut allergy. He said the peanut allergy rate is growing in the US for unknown reasons.
Peanuts are the food allergen most likely to cause anaphylaxis and death, Dr. Mustafa says. He adds that because peanuts are such common ingredients, as many as 15% of those with allergies have accidentally ingested peanuts at some time. These facts combined have turned peanut allergies into a major health concern, he said.
Dr. Mustafa says that peanut allergic reactions develop into skin reactions 80% to 90% of the time, such as:
He says more severe symptoms and signs of allergic peanut reactions include:
- nausea and vomiting,
- low blood pressure,
- increased heart rate,
- fainting, and
- behavioral changes (particularly in children).