The European Commission (EC) has granted approval for the extension of the indication of Palforzia (defatted powder of Arachis hypogaea L., semen (peanut)) for the treatment of peanut allergy in toddlers aged 1 through 3. This decision allows for earlier intervention in managing peanut allergies and covers all 27 European member states and the three European Economic Area states (Iceland, Liechtenstein, and Norway).
This approval follows the U.S. Food and Drug Administration (FDA) approval in July 2024. Palforzia is now the first and only EMA and FDA-approved oral immunotherapy for toddlers with a confirmed diagnosis of peanut allergy.
Clinical Significance of Early Intervention
According to Dr. Katharina Blümchen, Professor at the University of Medicine of Frankfurt, "Peanut allergy is one of the most frequent food allergies. Early intervention is crucial to reduce the risks of accidental exposure and may be very important in improving long-term outcomes. The approval of Palforzia for toddlers represents for the medical community a meaningful advancement in managing allergy at a pivotal stage in a child’s development."
Mechanism of Action and Desensitization
Palforzia is designed to gradually increase the body’s ability to tolerate small amounts of peanut through carefully controlled and supervised initial dose escalation, up-dosing, and maintenance. This desensitization process aims to reduce the risk of severe allergic reactions from accidental exposure to peanut allergens.
Supporting Clinical Data
The approval is based on data from the Phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study, published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia in peanut-allergic children aged 1 to 3 years, meeting all its primary and secondary efficacy endpoints and demonstrating a favorable safety profile.
The POSEIDON study was an international, randomized (2:1), double-blind, placebo-controlled trial that enrolled patients based on criteria including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge.
In the POSEIDON study, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of Palforzia or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit double-blind, placebo-controlled food challenge (DBPCFC).
Stallergenes Greer's Commitment
"The approval of Palforzia by the European Commission highlights the need for a treatment to help alleviate the burden of peanut allergy for young patients and their family," said Michele Antonelli, CEO of Stallergenes Greer. "In addition to the risk of severe reactions from accidental exposure, peanut allergy can have significant psychological consequences on disease sufferers and their families while negatively impacting quality of life. We are proud of this milestone which highlights Stallergenes Greer’s commitment to the patients and healthcare professionals we serve."
