Peanut Allergy: The FDA Treatment

Administrators with the FDA (Food And Drug Administration) have confirmed Aimmune Therapeutics’ Peanut (Arachis hypogaea) Allergen Powder-deep (Palforzia) to relieve allergic reactions, including anaphylaxis, that can happen with accidental disclosure to peanuts.

Dealing with this oral immunotherapy may be started in individuals ages four years to 17 years with a valid diagnosis of peanut allergy. It might be maintained in individuals four years of age and better. Those who take this treatment need to continue to avoid peanuts in their diets.

FDA-Approved Therapy

“Peanut sensitivity concerns approximately 1 million children in the US, and only 1 out of 5 of these children will abandon their disease. Because there is no cure, allergic people must surely avoid exposure to prevent harsh and possibly life-threatening effects,” stated Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a prepared statement.

“Even with strict restraint, inadvertent exposures can and do happen. When used in combination with peanut avoidance, Palforzia presents an FDA-approved therapy option to help decrease the risk of these allergic responses in children with peanut anaphylaxis.”

Allergic responses to peanut are random in occurrence, and in how they present, with some people experiencing sharp reactions from even trace amounts. Visible symptoms can occur within seconds of presentation. They might involve skin reactions, digestive discomfort, or more severe reactions, such as the constriction of the throat and airways, and loss of enough blood flow to vital organs of the body.

Antihistamines and epinephrine can be used to treat allergic reactions, but sharp results can be fatal even with appropriate, prompt therapy. Aimmune Therapeutics’ medicine cannot be used for the pressure treatment of allergic reactions, including anaphylaxis.

Treatment With This Peanut Immunotherapy

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 tablets or sachet and associated with a small amount of semisolid food‑such as applesauce, yogurt, or pudding‑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 the direction of a health care expert in a health care setting with the capacity to handle potentially critical allergic reactions, including anaphylaxis.

While anaphylaxis might happen at any time during therapy with this medication, patients are at the 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 extended dose level, the sufferer may continue that dose level every day at home.

After a sufferer completes all Up-Dosing levels, they may begin the daily support dose. Patients who undergo special allergic effects due to the procedure may need to discontinue nursing or have their dosing schedule changed.

The effectiveness of oral immunotherapy is approved by a randomized, double-blind, placebo-controlled investigation sent in the US, Canada, and Europe in about 500 peanut-allergic people.

Efficacy was estimated by assessing the percentage of study participants tolerating an oral test 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 six months of maintenance therapy. 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 receivers.

The security 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 treatment should not be applied to those with independent asthma.

Additionally, the Biologics License Application for the peanut allergen powder combined efficacy and security data from 7 clinical studies, including the phase 3 PALISADE and RAMSES clinical cases. Data from the Phase 2 ARC001 research and the ARC002 open-label follow-on study also were involved, as well as data from ARC004, ARC008, and ARC011, which are continuing education.

To Sum Up

To decrease the risk of anaphylaxis compared with peanut allergen powder, the FDA needs a Risk Evaluation and Mitigation Strategy (REMS) with this approval, which appends elements to ensure safe use. The treatment will only be possible through specially certified health care providers, health care environments, and medicines to sufferers who are registered in the REMS program.

“Peanut allergy is more popular now than ever before and has converted pressing public health care. The food allergy agreement has been anxiously awaiting an FDA-approved therapy that can help mitigate allergic stability to peanut and, as allergists, we want nothing more than to have a treatment option to offer our sufferers that have confirmed both the safety and ability to truly impact the lives of patients who live with peanut allergy,” stated 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, in an instant announcement.