The First Peanut Allergy Drug On the Cusp of FDA Approval

AR101 is an investigational biologic oral immunotherapy produced by Aimmune therapeutics.  If that sounds like a mouthful, it is, so let’s break down what that really means. AR101 will be a commercially available “drug” with a proposed trade name of Palforzia. As such, it requires approval by the Food and Drug Administration (FDA). It is currently considered “investigational” because it has not been approved by the FDA and is still under investigation. The term “biologic” refers to a product that is isolated from natural sources and not chemically manufactured. As explained by the American Academy of Allergy, Asthma & Immunology, “oral immunotherapy (OIT) refers to feeding an allergenic individual an increasing amount of allergen with the goal of increasing the threshold that triggers a reaction.”  In the case of AR101, the product is designed for peanut allergic patients and the treatment goal is to reduce the frequency and severity of allergic reactions due to accidental peanut exposure. 

Peanut allergic patients would be introduced to increasing amounts of AR101 over the course of months with the goal of teaching the immune system to tolerate large amounts of peanut protein without reacting.  Once patients reach the final dose, they will need to stay on that dose indefinitely to maintain their desensitization. The drug itself is peanut flour contained within a capsule. It is important to note that this drug is not a cure for peanut allergies, but instead a way to significantly reduce risk of severe or life-threatening reactions to peanut exposure. 

In one of the Phase 3 studies known as the PALISADE trial, two-thirds of patients (67.2%) on the AR101 therapy ages 4-17 years old tolerated at least a 600-mg dose of peanut protein compared to only 4% of the placebo patients.  In addition, half of the patients (50.3%) on AR101 ages 4-17 tolerated a 1000-mg dose of peanut protein compared to only 2.4% of placebo patients. For perspective, one peanut kernel contains between 250-300 mg peanut protein.

On September 13th, AR101 went before the Allergenic Products Advisory Committee, an expert advisory panel of the FDA. The committee made of nine individuals voted 7-2 in support of the drug efficacy and 8-1 in support of its safety.  While the FDA does not have to follow the recommendations of the expert panel that is usually the case and a decision by the FDA is expected by early 2020.

This is groundbreaking in the world of allergy and revolutionary to those families affected by peanut allergy. This drug has the impact of dramatically changing the lives of those with peanut allergies and their families. Peanut allergy is a disease that greatly affects all in the family, creating major anxiety around simple things like going to a restaurant, traveling, and even attending school. Charleston Allergy & Asthma is excited for this innovative change on the allergy horizon. If you are interested in learning more, please contact one of our board-certified allergists at 843-881-2030 or visit us online

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