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October 30, 2020 04:00am
By Jennifer Gershman, PharmD, CPh
Officials with the FDA have approved Aimmune Therapeuticsâ€™ Peanut (Arachis hypogaea) Allergen Powder-dnfp (Palforzia) to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.
Officials with the FDA have approved Aimmune Therapeutics’ Peanut (Arachis hypogaea) Allergen Powder-dnfp (Palforzia) to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.
Treatment with this oral immunotherapy may be initiated in individuals ages 4 years to 17 years with a confirmed diagnosis of peanut allergy, and may be continued in individuals 4 years of age and older. Those who take this therapy must continue to avoid peanuts in their diets.
“Peanut allergy affects approximately 1 million children in the US, and only 1 out of 5 of these children will outgrow their allergy. Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a prepared statement.
“Even with strict avoidance, inadvertent exposures can and do occur. When used in conjunction with peanut avoidance, Palforzia provides an FDA-approved treatment option to help reduce the risk of these allergic reactions in children with peanut allergy.”
Allergic reactions to peanut are unpredictable in occurrence, and in how they present, with some individuals experiencing severe reactions from even trace amounts. Physical symptoms can develop within seconds of exposure and may include skin reactions, digestive discomfort, or more dangerous reactions, such as constriction of the throat and airways, and loss of adequate blood flow to vital organs of the body. Antihistamines and epinephrine can be used to treat allergic reactions, but severe reactions can be fatal even with appropriate, prompt treatment. Aimmune Therapeutics’ medication cannot be used for the emergency treatment of allergic reactions, including anaphylaxis.
The FDA-approved peanut allergen powder is manufactured from peanuts and packaged in pull-apart color-coded capsules for Dose Escalation and Up-Dosing, and in a sachet for maintenance treatment. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid foodâ€‘such as applesauce, yogurt, or puddingâ€‘for consumption.
Treatment with this peanut immunotherapy consists of 3 phases: Initial Dose Escalation, Up-Dosing, and Maintenance. The Initial Dose Escalation phase is given on a single day. 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 with the ability to manage potentially severe allergic reactions, including anaphylaxis.
While anaphylaxis can occur at any time during therapy with this medication, patients are at highest risk during and after the Initial Dose Escalation, and the first dose of each Up-Dosing level. During Up-Dosing, if the patient tolerates the first dose of an increased dose level, the patient may continue that dose level daily at home. After a patient completes all Up-Dosing levels, they may begin the daily maintenance dose. Patients who experience certain allergic reactions due to the therapy may need to discontinue treatment or have their dosing schedule modified.
The effectiveness of the oral immunotherapy is supported by a randomized, double-blind, placebo-controlled study conducted in the US, Canada and Europe in approximately 500 peanut-allergic individuals. Effectiveness was assessed by evaluating the percentage of study participants tolerating an oral challenge with a single 600 mg dose of peanut protein (twice the daily maintenance dose of the peanut allergen powder) with no more than mild allergic symptoms after 6 months of maintenance treatment. The results showed that 67.2% of these immunotherapy recipients tolerated a 600 mg dose of peanut protein in the challenge, compared to 4.0% of placebo recipients.
The safety of the medication was assessed in 2 double-blind, placebo-controlled studies in approximately 700 peanut-allergic individuals. The most commonly reported adverse effects of this therapy 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. This therapy should not be administered to those with uncontrolled asthma.
In addition, the Biologics License Application for the peanut allergen powder 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 open-label follow-on study also were included, as well as data from ARC004, ARC008 and ARC011, which are ongoing studies.
To mitigate the risk of anaphylaxis associated with peanut allergen powder, the FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) with this approval, which includes elements to assure safe use. The therapy will only be available through specially certified health care providers, health care settings, and pharmacies to patients who are enrolled in the REMS program.
“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,” said Christina Ciaccio, M.D., 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, in a prepared statement.
“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.”