FDA Gives OK to Peanut Allergy Oral Immunotherapy
What Patients and Families Need to Know
The U.S. Food and Drug Administration (FDA) committee has approved the use of an oral immunotherapy (OIT) treatment for peanut allergy. The treatment is called Palforzia™ and it’s manufactured by Aimmune Therapeutics. It’s designed to reduce the frequency and severity of allergic reactions, including life-threatening anaphylaxis, in children ages 4-17 after accidental exposure to peanut.
Here’s how Palforzia works:
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 Palforzia 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.
How is Palforzia prescribed?
Palforzia is available only through a Risk Evaluation and Mitigation Strategy (REMS). Requirements of the REMS include:
- the prescribing physician and patient must be enrolled in the REMS prior to initiation of treatment;
- the initial dose escalation and the first dose of each up-dosing level must be administered in a certified healthcare setting; epinephrine must always be immediately available to patients; and
- pharmacies/distributors must be certified with the REMS and dispense PALFORZIA only to certified healthcare settings or to patients who are enrolled in the REMS.
Aimmune will provide resources to patients and families who, upon consultation with their physician, wish to seek treatment with PALFORZIA. These resources will include educational materials, a dedicated call center, a co-pay program for eligible patients, and a Patient Assistance Program to provide PALFORZIA at no cost to eligible patients.
Can this treatment be taken at home?
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.
In September 2019, the FDA’s Allergenic Products Advisory Committee voted 7-2 that the data showed Palforzia™ (also called AR101) was effective and 8-1 that the safety data was sufficient to support the use of the treatment. During a hearing, Allergy & Asthma Network’s Director of Advocacy Charmayne Anderson addressed the Allergenic Products Advisory Committee in support of AR101 as a peanut allergy treatment. Here are excerpts:
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.