Another Step Forward for Peanut Allergy Oral Immunotherapy

What Patients and Families Need to Know

A U.S. Food and Drug Administration (FDA) committee voted on Sept. 13 to support the use of a biologic oral immunotherapy (OIT) to treat peanut allergy. The treatment is designed to reduce the frequency and severity of allergic reactions, including life-threatening anaphylaxis, in children ages 4-7 after accidental exposure to peanut.

The Allergenic Products Advisory Committee voted 7-2 that the data showed Aimmune Therapeutics’ AR101 (proposed trade name is Palforzia™) was effective and 8-1 that the safety data was sufficient to support the use of the treatment.

If approved by FDA, here’s how Palforzia would work, according to the American Academy of Allergy, Asthma & Immunology (AAAAI):

Peanut allergy patients would be given a capsule with peanut powder that can be mixed into food. When taking it, patients consume a controlled dose of peanut protein, with the dose gradually increasing over time. Eventually a level of peanut tolerance is reached so that if there’s an accidental exposure, it won’t trigger a severe allergic reaction.

This is not a peanut allergy cure. Patients must continue to avoid peanut products and may need to continue undergoing OIT even after a tolerance level is reached.

The treatment is not for every peanut allergy patient, however. It’s important for patients and families to work together with a doctor to determine if AR101 is an appropriate treatment.

A 2018 study involving AR101 revealed two-thirds of participants were able to tolerate the equivalent of at least two peanuts per day, but it did not include people with severe peanut allergy or asthma and numerous participants dropped out of the study due to adverse reactions.

When might the treatment be available?

If the FDA approves AR101, it may be available by the end of 2019, but researchers stress there is much more to be done to fine-tune the therapy.

Board-certified allergist Julie Wang, MD, a clinical researcher at the Jaffe Food Allergy Institute, Icahn School of Medicine at Mount Sinai, commented: “We’ve seen very good outcomes for many of our peanut-allergic patients who have taken AR101 in clinical trials. The Phase 3 study answered several important questions about safety and efficacy about this promising treatment approach. However we are still seeking data to improve our understanding of which patients might benefit the most from this treatment and how to effectively optimize safety and efficacy.”

Researchers also emphasize this is not a home treatment; it should only be done under the care of a qualified allergy specialist and at a medical facility where epinephrine – the first-line treatment for a severe allergic reaction – is readily available.

During the Sept. 13 hearing, Allergy & Asthma Network Director of Advocacy Charmayne Anderson addressed the Allergenic Products Advisory Committee in support of AR101 as a peanut allergy treatment. Here are excerpts from Charmayne’s testimony:



Statement by Allergy & Asthma Network
Safety and Efficacy of Peanut [Arachis hypogaea] Allergen Powder manufactured by
Aimmune Therapeutics, Inc. at the U.S. Food and Drug Administration
September 13, 2019

I am here specifically on behalf of the millions of Americans living with peanut allergy. The prevalence and burden is growing, and these patients live in constant fear of accidental exposure. It is this segment that accounts for the majority of the $25 billion per year in direct and indirect costs based on the literature. But these are not nameless, faceless statistics. These are real people with families, hopes, dreams and fears. I am here to tell their story and to bring forth a true societal perspective.

First, let’s meet Allie from Philadelphia. Allie is a 34-year-old young professional who lives with multiple food allergies including peanut. She is beautiful, intelligent and brave. She has taught elementary school abroad and stateside. She has written a blog about her challenges living with life-threatening allergies for the past ten years. Yet, every day, at every meal, she must remain hypervigilant to avoid a life-threatening reaction. She takes significant steps to ensure her safety, including skipping meals when dining out and translating chef cards in many different languages. Even so, each year she averages at least 2-3 accidental exposures resulting in a reaction.

Next, I would like to introduce you to Thomas from New York City. Thomas is a hard-working father of two and husband. He suffered every parent’s nightmare in 2014 when his 3-year-old son Elijah died from a severe life-threatening allergy while at preschool. Even though Thomas and his wife took great strides in making sure his childcare providers were aware of Elijah’s food allergy and prepared to administer epinephrine, an accidental exposure occurred and within minutes this man’s world was turned upside down. His family will never be the same. Avoidance alone is simply not enough, as the literature reflects at least 30% of patients experience accidental exposure each year and most go unreported.

Finally, there is the story of Karson. From the outside looking in Karson is a vibrant 14-year-old preparing for her first days as a high school volleyball player outside of Nashville, Tennessee. The truth is she lives with a constant level of fear and anxiety. Fear that the next bite of pizza may be the one to land her in the ER. Anxiety that her friends may have to administer epinephrine simply to save her life. Fear that her mother will never see her grow into the confident, successful woman, wife and mother Karson longs to be.

Allergy & Asthma Network believes patients deserve better options – avoidance alone is simply not enough. We will continue to advocate for appropriate use of innovative treatments and believe that when the right treatment is selected for the right patient at the right time, it inevitably provides a financial benefit to individual patients and the healthcare system.

Significant scientific advancements in peanut allergy diagnosis and treatment are promising. Patients like Allie, Elijah and Karson are depending on you to ensure this innovation actually reaches the community it can help the most. Innovation without access only breeds frustration.

Now is the time for FDA and all stakeholders to come together and find compromise to ensure access and affordability to the patients who truly need these treatments. It will take all of us working together to advance and address the systemic changes needed.