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What You Need to Know About the First Peanut Allergy Treatment Approved by the FDA

AAAAI News Release

February 1, 2020

April Presnell
(414) 272-6071

The AAAAI offers information for patients and their families about this new treatment option, what it means, and why it won’t be right for everyone.

MILWAUKEE, WI – The Food and Drug Administration (FDA) has approved the very first peanut allergy treatment: Palforzia, a standardized oral immunotherapy (OIT) product for peanut allergy. This is the first treatment for any food allergy to be approved by the FDA. In light of this groundbreaking approval, the American Academy of Allergy, Asthma & Immunology (AAAAI) is here to share information about OIT to help patients understand this therapy and what it means for their treatment options.

“Most allergists trained at a time when we never thought we’d see a treatment for food allergy. Previously we recommended carrying injectable epinephrine and strict avoidance, which in some cases leads to serious or even life-threatening allergic reactions with inadvertent food exposures. Now, we have the first FDA approved treatment for food allergy, that when used in combination with avoidance measures, can reduce the possibility that an inadvertent exposure will lead to a serious allergic reaction,” said AAAAI President David M. Lang, MD, FAAAAI, who is also Chair of the Allergy/Immunology Department in the Respiratory Institute at Cleveland Clinic.

What is OIT?
OIT involves feeding an increasing amount of an allergen to an individual allergic to that specific allergen. The goal of OIT is to increase the threshold that triggers an allergic reaction.
For example, the newly approved Palforzia is a capsule filled with peanut powder that can be mixed into food. Patients taking this capsule are therefore exposed to controlled doses of peanut protein. Over time, the dose will gradually increase with the hopes that higher doses will induce a level of tolerance that prevents allergic reactions to accidental peanut exposure.

It is important to remember that OIT is not a cure for peanut allergy, and it is likely an individual starting this therapy will need to remain on it indefinitely. Patients utilizing this therapy will still be expected to avoid dietary peanut and carry an epinephrine auto-injector.  

Who Will Benefit From This Treatment?
OIT will not be right for every patient. It is not a “one size fits all” approach. How to predict which individuals will respond to OIT and which individuals will be at highest risk of side effects (including anaphylaxis) has not been clearly determined, and there are many other important questions about OIT that require ongoing study.

The AAAAI encourages patients and families to engage with an allergist/immunologist to discuss the risks, benefits, and alternatives of OIT and all other emerging treatments for food allergy. Ultimately, the choice of treatment, including that of active non-intervention, will be based on individual and family factors after careful discussion with one’s physician.

“Patients and their families will need to understand the realities of these new therapies. As physicians, we must invest the time to explain the potential for benefit compared with the potential for harm/burden, and permit patients and families to express their values and preferences, allowing them to participate in the medical decision making process to determine whether they desire to proceed with food oral immunotherapy,” said Dr. Lang.

Who Can Provide More Details?
Food allergy experts from the AAAAI are available to speak about this new therapy and what it means for patients. If you’re a reporter looking to speak with an expert, please email If you’re a patient, the AAAAI’s Find an Allergist/Immunologist service will allow you to find a trusted AAAAI member specialist close to home.

You can learn more about the current state of oral immunotherapy at the AAAAI’s website,
The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has nearly 7,000 members in the United States, Canada and 72 other countries.