Stallergenes Greer, a biopharmaceutical company specializing in allergen immunotherapy (AIT), has announced a significant milestone with the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The recommendation is for the extension of the existing indication of Palforzia® (defatted powder of Arachis hypogaea L., semen, or peanuts) to include the treatment of toddlers aged 1 to 3 with a confirmed diagnosis of peanut allergy. If approved by the European Commission, this would make Palforzia® the first EMA-approved oral immunotherapy (OIT) treatment for toddlers with peanut allergies, offering hope for young children and their families.
Palforzia® works by gradually desensitizing patients to peanut allergens through a carefully controlled treatment plan. This plan involves an initial dose escalation, followed by up-dosing and a maintenance phase, all under strict supervision. The new extension of the indication would allow treatment to start at an earlier age, helping reduce the risk of severe allergic reactions from accidental peanut exposure in young children. This expanded use could significantly improve the quality of life for families dealing with the complexities of managing peanut allergies.
The CHMP’s positive recommendation is currently under review by the European Commission, which grants central marketing authorizations in the European Union. If approved, this would cover all 27 EU member states and three European Economic Area (EEA) countries—Iceland, Liechtenstein, and Norway. Notably, the U.S. Food and Drug Administration (FDA) granted the same extension for Palforzia® in toddlers in July 2024, marking significant progress in expanding treatment access.
The regulatory submission to the EMA is based on promising data from the Phase 3 POSEIDON study (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization), which was published in the New England Journal of Medicine Evidence in 2023. The study evaluated Palforzia® in peanut-allergic children aged 1 to 3 years and successfully met all primary and secondary efficacy endpoints, demonstrating a favorable safety profile. This study was pivotal in providing the necessary evidence for the extension of Palforzia®’s indication to younger children.
Elena Rizova, Chief Medical Officer of Stallergenes Greer, commented on the milestone, saying, “The positive recommendation of Palforzia® is a significant step forward for younger children with peanut allergies and their families. This achievement reflects our ongoing commitment to providing innovative solutions for allergy sufferers.”
Stallergenes Greer is committed to advancing its efforts to broaden access to Palforzia® and other allergy treatments. The company’s portfolio includes various allergen immunotherapy solutions for food allergies, respiratory allergies, and insect venom allergies. These range from oral immunotherapy to sublingual tablets, liquids, and subcutaneous formulations, paving the way for personalized and precision-based treatment options tailored to patient needs.
About Palforzia®
Palforzia® is currently approved by the European Medicines Agency (EMA) for patients aged 4 to 17 with a confirmed diagnosis of peanut allergy and may be continued for patients aged 18 and older. It is intended to be used in conjunction with a peanut-avoidant diet to mitigate allergic reactions, including anaphylaxis, that may occur with accidental peanut exposure. In the U.S., the FDA approved Palforzia® for use in patients aged 1-17 years. The treatment may be initiated in children as young as one year, offering protection against allergic reactions while still emphasizing the importance of avoiding peanuts. However, it is not intended for emergency treatment of allergic reactions, including anaphylaxis.
Stallergenes Greer acquired the rights to Palforzia® in September 2023 from Aimmune Therapeutics, which had originally developed the treatment.
About the POSEIDON Phase 3 Study
The POSEIDON study (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) is a randomized, double-blind, placebo-controlled Phase 3 clinical trial conducted in North America and Europe. The study evaluated the efficacy and safety of Palforzia® in children aged 1 to 3 with peanut allergies. The trial’s design included dose-escalation over 22 weeks, followed by a maintenance phase lasting approximately six months. At the conclusion of the study, participants underwent a double-blind food challenge to assess the impact of Palforzia® on peanut allergy tolerance.
About Stallergenes Greer International AG
Headquartered in Baar, Switzerland, Stallergenes Greer International AG is a global healthcare company dedicated to the diagnosis and treatment of allergies, including respiratory, food, and venom allergies. The company focuses on the development and commercialization of allergen immunotherapy products and services. It is the parent company of Greer Laboratories, Inc. in the U.S. and Stallergenes SAS in France. Stallergenes Greer is committed to offering tailored solutions to allergy sufferers, helping them manage their conditions effectively and improve their quality of life.
