On Friday, September 13th, the Allergenic Products Advisory Committee of the Food and Drug Administration (FDA) voted to recommend approval of an oral immunotherapy (OIT) product for peanut allergy.
The product is expected to be called Palforzia, previously known as AR101. Clinical trials on AR101 have been conducted at Atlanta Allergy & Asthma’s research facility over the past several years.
Although the FDA still needs to complete its review and issue a final decision, Atlanta Allergy & Asthma is very encouraged as this means we are one step closer to the first treatment for any type of food allergy.
“This is a very positive development from the Advisory Committee, since it signals the potential approval of a therapy for our patients with peanut allergy,” says Dr. Stanley Fineman of Atlanta Allergy & Asthma. “We’ve been fortunate to have experience with this product in the research trials we’ve been performing here at Atlanta Allergy & Asthma the last several years. When it is formally approved it will be a game-changer in the management of peanut allergy.”
Palforzia is a capsule filled with peanut powder and is given in carefully controlled doses. The doses increase over time with the goal of inducing a level of tolerance sufficient to prevent a severe allergic reaction if peanut protein is accidentally ingested. It is important to note that this is a treatment, not a cure. Patients will need to discuss the risks, benefits, and alternatives of OIT with their board certified allergist/immunologist.
Palforzia’s indication for treatment is for patients 4 to 17 years with a confirmed diagnosis of peanut allergy. If you have questions regarding food allergy diagnosis and available treatment options, speak with one of our 16 physicians.