FDA OKs First Immunotherapy for Peanut Allergy

Officials with the FDA have approved Aimmune Therapeutics’ peanut (Arachis hypogaea) allergen powder-dnfp (Palforzia), an oral immunotherapy indicated for the mitigation of allergic reactions that may occur with accidental exposure to peanuts.¹

With this approval, the peanut allergen powder is the first FDA-approved treatment for patients with peanut allergy. The immunotherapy is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.¹

The treatment is a powder manufactured from peanuts and packaged in pull-apart color-coded capsules for dose escalation and up-dosing, and in a sachet for maintenance treatment, according to the FDA. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food for consumption.²

The Biologics License Application for this oral immunotherapy included efficacy and safety data from 7 clinical studies, including the phase 3 PALISADE and RAMSES clinical trials. Data from the phase 2 ARC001 study and the ARC002 follow-on study were also included, along with data from ARC004, ARC008, and ARC011, which are ongoing.¹

Individuals with confirmed diagnosis of peanut allergy may be treated with the peanut allergen powder. Initial Dose Escalation may be administered to patients aged 4 through 17 years of age. Up-Dosing and maintenance may be continued in patients 4 years of age and older, according to Aimmune.¹

Efficacy was assessed by evaluating the percentage of study participatants tolerating an oral challenge with a single 600-mg dose of peanut protein (twice the daily maintenance dose of Palforzia) with no more than mild allergic symptoms after 6 months of maintenance. According to the data, 67.2% of patients treated with the peanut allergen powder tolerated a 600-mg dose of peanut protein in the challenge, compared with 4% of those in the placebo group.²

The treatment consists of Initial Dose Escalation, Up-Dosing, and maintenance phases, according to the FDA. The Initial Dose Escalation phase is given on a single day, whereas the Up-Dosing phase consists of 11 increasing dose levels and occurs over several months. Initial Dose Escalation and the first dose of each Up-Dosing level are administered under supervision of a health care professional in a health care setting. If the patients tolerates the first dose of an increased dose level during Up-Dosing, they may continue that dose level daily at home. Once a patient completes all Up-Dosing levels, they may begin the daily maintenance dose.²

The safety profile of the peanut allergen powder was assessed in approximately 700 peanut-allergic individuals. The most commonly reported adverse effects were abdominal pain, vomiting, nausea, tingling in the mouth, itching, cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.²

Patients who experience certain allergic reactions due to the treatment may need to discontinue or have their dosing schedule modified.²

“Peanut allergy is more common now than ever before and has become a serious public health concern. The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” Christina Ciaccio, MD, associate professor of pediatrics and medicine and chief of allergy/immunology and pediatric pulmonary medicine at the University of Chicago Medical Center and Biological Sciences, said in a statement.¹ “With today’s approval of Palforzia, we can–for the first time–offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”

To mitigate the risk of anaphylaxis, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) with this approval.²