10. February 2021
Update: EU and FDA approve peanut protein treatment for peanut allergy

When children and teenagers with a peanut allergy ingest peanut protein in controlled doses, their allergy symptoms improve.

The US FDA approved the first drug for this treatment in January 2020. It has also been approved in the EU since mid-December 2020 for children from four to 17 years of age. According to the manufacturer, it will be launched on the market in May 2021.


In the US, “every three minutes, a food allergy reaction sends someone to the emergency room ”, says Chicago paediatrician Christina Ciaccio. She is the co-author of an international study on immunotherapy for peanut allergy in children, in which researchers from Charité Universitätsmedizin Berlin were also involved. Most food allergy emergencies and deaths in the US are due to peanut allergies.


The US Food and Drug Administration (FDA) approved the first drug for peanut allergy immunotherapy in January 2020. It is marketed in the US under the name Palforzia®. “I can’t stress enough what a game changer it will be for allergists and patients to have an FDA-approved product for peanut allergy treatment”, says Ciaccio.

EU approval since December 2020

The drug was approved in the EU later than in the US because there were initially insufficient data on European patients. Too few Europeans were included in the international PALISADE study, said Kirsten Beyer at the Online Allergy Day of the German Allergy and Asthma Association (DAAB) in June 2020. Beyer is head of the Paediatric Allergy Study Centre and professor at Charité Universitätsmedizin Berlin.


In the meantime, however, the data from the second major study have been published – the ARTEMIS Study (AR101 Trial in Europe Measuring Oral Immunotherapy Success), which was conducted exclusively in Europe. It included 175 children and adolescents between the ages of four and 17.
The treatment was considered successful if the study participants, in the final provocation test, were able to tolerate at least 1,000 mg of peanut protein and displayed only mild allergy symptoms. This was the case for 58.3 per cent of the patients who received Palforzia. The longer the patients took the drug, the more of them were able to tolerate 1,000 mg of peanut protein. Long-term therapy with Palforzia therefore appears to further improve peanut tolerance.
Nevertheless, people taking the medication must also carry an adrenaline pen with them in case of emergencies.


Patients will initially have to bear the costs for treatment. “EU approval does not mean that health insurance providers will cover the costs”, says Beyer.

About the PALISADE Study

Approval of the drug in the US was primarily based on a study published in the prestigious New England Journal of Medicine. It investigated whether very small amounts of peanut protein ingested regularly by children and teenagers with a peanut allergy would reduce their symptoms. The study is also known by its abbreviation, PALISADE, which stands for “Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization”. AR101 is a medication based on peanut protein. It is taken orally and therefore swallowed.

How did the PALISADE team conduct the study?

Three quarters of the 496 study participants aged between 4 and 17 years received the medication, while a quarter received a placebo. For the patients treated with AR10, the dosage of the medication was increased every two weeks. At the end of the trial, all participants were given peanuts and monitored for allergy symptoms and their severity.

What were the results of the PALISADE study?

At the end of the trial, 67 per cent of the children and teenagers who received the medication were able to tolerate a small amount of peanuts. The dose at which no allergy symptoms appeared was equivalent to about two peanut kernels.

Only four per cent of the participants who received the placebo were able to tolerate two peanut kernels without symptoms.

However, treatment with AR101 caused adverse effects such as gastrointestinal, skin and respiratory problems. As a result, one in ten patients withdrew early from the study.

How can the findings help?

The treatment cannot ‘cure’ peanut allergies, but it may prevent peanut allergy sufferers who have received treatment with peanut protein from requiring a trip to the emergency room with life-threatening symptoms if they accidentally ingest trace amounts of peanuts.

The preparation is produced by the Nestlé subsidiary Aimmune. According to the manufacturer, the launch is targeted for May 2021.

References – Studies

O’B Hourihane J et al. Efficacy and safety of oral immunotherapy with AR101 in European children with a peanut allergy (ARTEMIS): a multicentre, double-blind, randomised, placebo-controlled phase 3 trial. Lancet Child Adolesc Health. 2020 (10):728-39


PALISADE Group of Clinical Investigators. AR101 Oral Immunotherapy for Peanut Allergy. N Engl J Med. 2018 Nov 22;379(21):1991-2001

References – lectures and press releases

“Lebensmittel-Allergie – Neue Therapien eröffnen Chancen (Food allergy – new therapies open up opportunities”) – lecture by Prof. Dr. Kirsten Beyer at the Online Allergy Day of DAAB e.V., 21 June 2020


FDA approves peanut allergy treatment for children and teens https://www.uchicagomedicine.org/forefront/pediatrics-articles/peanut-allergy-immunotherapy


Celine Müller. EU lässt Palforzia gegen Erdnussallergie zu (EU approves Palforzia for treatment of peanut allergy) – online article in DAZ dated 4 January 2021. [In German] Last retrieved on 18 January 2021


Sophie Shey. European Commission Approves Aimmune’s PALFORZIA® as First-Ever Treatment for Peanut Allergy in the EU. Press release of Aimmune from 21 December 2020. Last retrieved on 20 January 2021


Last updated: 20 January 2021