Positive CHMP opinion on the extension of the indication of Palforzia® for the treatment of young children with confirmed peanut allergy

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BAAR, Switzerland – Stallergenes Greer, a biopharmaceutical company specializing in allergen immunotherapy (AIT), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion on the extension of the existing indication for Palforzia® (degreased powder Arachis hypogea L., seed (peanut)) in the treatment of young children (aged 1 to three years) with a confirmed diagnosis of peanut allergy. If the European Commission agrees to increase the indication, Palforzia® will change into the first EMA-approved oral immunotherapy (OIT) medicine for young children with confirmed peanut allergy.

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Palforzia® is designed to steadily increase the body’s ability to tolerate small amounts of peanuts (desensitization) through rigorously controlled and supervised titration, escalation and maintenance of the starting dose. Expanding the indication, along with adjusting the contraindications, would allow treatment to be began at an earlier age, thus giving young children and their families the opportunity to scale back the risk of severe allergic reactions on account of accidental exposure to peanut allergens.1

The CHMP advice is being reviewed by the European Commission, which is responsible for issuing central marketing authorizations in the European Union. If granted, marketing authorization will cover all 27 European Member States and three European Economic Area countries (Iceland, Liechtenstein and Norway). In July 2024, the US Food and Drug Administration (FDA) approved the extension of the indication for Palforzia® to make use of in young children.

Regulatory information is predicated on data from POSEIDON Phase 3 (Pnut ABOUTImmunotherapy Sscience of meArly ANDintervention for DessentializationON) study, which was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the effectiveness and safety of Palforzia® in children aged 1 to three years with peanut allergy, meeting all primary and secondary efficacy endpoints and demonstrating favorable safety profile.2

“The positive recommendation for Palforzia® represents a significant step forward for both younger children with peanut allergies and their families. This milestone builds on Stallergenes Greer’s long-standing commitment to providing innovative solutions for the benefit of allergy sufferers.” says Elena Rizova, medical director of Stallergenes Greer.

As Stallergenes Greer continues to expand access to Palforzia®, the company continues to strive to supply solutions tailored to patient needs. With a comprehensive portfolio including oral immunotherapy for the treatment of food allergies, sublingual tablets and liquid solutions, and subcutaneous preparations for the treatment of respiratory allergies and bug venoms, Stallergenes Greer is paving the way for personalized, precision allergen immunotherapy.

ABOUT PALFORZIA®

Palforzia® is indicated by the European Medicines Agency (EMA) in the European Union, the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, and Swissmedic in Switzerland for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. Palforzia® will be continued in patients aged 18 years and over. Palforzia® must be utilized in conjunction with a eating regimen avoiding peanuts.

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Palforzia® can also be approved by the U.S. Food and Drug Administration (FDA) for people ages 1-17 to alleviate allergic reactions, including anaphylaxis, which will occur after accidental exposure to peanuts. The treatment is approved for use in patients with a confirmed diagnosis of peanut allergy; The starting dose could also be increased in patients aged 1 to 17 years. Dose escalation and maintenance therapy may proceed in patients 1 12 months of age and older. Palforzia must be utilized in conjunction with a eating regimen avoiding peanuts. Restrictions on use: Not indicated for use in emergency cases of allergic reactions, including anaphylaxis.

Stallergenes Greer acquired the rights to Palforzia® in September 2023

ABOUT THE POSEIDON PHASE 3 TRIAL

POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, Clinictrials.gov number NCT03736447) is a global, randomized (2:1), double-blind, placebo-controlled, phase 3 study that evaluated the efficacy and safety of Palforzia® in peanut -allergic children aged 1 to three years in North America and Europe.

The POSEIDON study was accomplished by Aimmune Therapeutics, part of Nestlé Health Science, before Nestlé sold Palforzia® to Stallergenes Greer in September 2023.

Several inclusion criteria were included for inclusion, including a documented clinical history of peanut allergy, positive skin tests and/or elevated blood levels of anti-peanut antibodies, and dose-limiting symptoms after ingestion of single doses of peanut protein starting from 3 to ≤300 mg inside positive, double-blind, placebo-controlled food challenge.

In the POSEIDON study, patients underwent a dose escalation period of roughly 22 weeks until they reached a dose of 300 mg per day of Palforzia® or placebo, after which continued at this dose for roughly six months. At the end of the study, patients underwent a double-blind, placebo-controlled food challenge (DBPCFC).

ABOUT STALLERGENES GREER INTERNATIONAL AG

Stallergenes Greer International AG based in Baar (Switzerland) is a worldwide healthcare company specializing in the diagnosis and treatment of respiratory, digestive and venom allergies through the development and commercialization of allergen immunotherapy services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (based in the United States) and Stallergenes SAS (based in France). More information will be found on the website www.stallergenesgreer.com.

1 Summary of Product Characteristics. Version September 6, 2024
2 https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300145

Palforzia®: © 2024, Société des Produits Nestlé SA or its affiliates

View source version on businesswire.com: https://www.businesswire.com/news/home/20241201331216/en/

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Katarzyna Kres
Tel: +33 (0)1 55 50 26 05
E-mail: catherine.kress@stallergenesgreer.com

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