Stallergenes Greer, a firm dedicated to allergen immunotherapy (AIT) solutions, has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a favorable opinion for broadening Palforzia’s existing use. This development is directed towards treating toddlers aged 1 to 3 with confirmed peanut allergies. Should the European Commission approve this expanded use, Palforzia would become the first oral immunotherapy (OIT) sanctioned by the EMA for toddlers with verified peanut allergy.
The purpose of Palforzia is to enhance the body’s tolerance to minute peanut amounts (desensitization) through a structured and supervised process involving initial dosage escalation, followed by up-dosing and maintenance. This expanded indication, alongside updated contraindications, allows for earlier treatment intervention, thereby reducing the likelihood of severe allergic reactions from unintended peanut exposure.
This recommendation from the CHMP is currently under the European Commission’s review, which holds the authority to provide central market authorizations across the EU. Upon approval, the marketing authorization would be applicable for all 27 EU states and the three European Economic Area countries: Iceland, Liechtenstein, and Norway. In addition, the US FDA approved the expansion in July 2024 for use in toddlers.
The regulatory application is supported by findings from the phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) trial, published in the New England Journal of Medicine Evidence in 2023. The trial assessed Palforzia’s effectiveness and safety for peanut-allergic children aged 1 to 3 years, achieving its main and additional efficacy targets while confirming a positive safety profile.
According to Elena Rizova, Stallergenes Greer’s chief medical officer, “The affirmative outlook on Palforzia presents a monumental advance for young children with peanut allergies, along with their families. This milestone underscores Stallergenes Greer’s unwavering dedication to pioneering innovative remedies for allergy sufferers.”
Stallergenes Greer’s ongoing mission to broaden Palforzia’s availability remains focused on patient-centered solutions. Their expansive range includes oral immunotherapy for food allergies, sublingual tablets and liquids, and injectable formulas addressing respiratory and insect venom allergies, illustrating Stallergenes Greer’s leadership in customized, precision allergen immunotherapy.
Palforzia, sanctioned by the EMA in the EU, MHRA in the UK, and by Swissmedic, serves patients aged 4 to 17 years diagnosed with peanut allergy. The medicine can continue in patients aged 18 and older, used alongside a diet avoiding peanuts.
In the US, Palforzia is FDA-approved for ages 1-17 to mitigate allergic reactions like anaphylaxis due to accidental peanut exposure, for those formally diagnosed with peanut allergy, with dosing and maintenance permissible from age 1. However, it is not intended for emergency allergic reaction treatments, including anaphylaxis.
Stallergenes Greer acquired Palforzia in September 2023.
POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization), identified as clinicaltrials.gov number NCT03736447, is a global, randomized (2:1), double-blind, placebo-controlled phase 3 trial testing Palforzia’s efficacy and safety in 1 to 3-year-old peanut-allergic children in North America and Europe.
Before Nestlé divested Palforzia to Stallergenes Greer in September 2023, Aimmune Therapeutics under Nestlé Health Science completed the POSEIDON study.
Eligibility hinged on certain criteria, such as documented peanut allergy history, positive skin tests, high blood peanut antibodies, and symptoms upon peanut protein ingestion beyond 3 to 300 mg in a positive double-blind, placebo-controlled food challenge.
The POSEIDON study involved a 22-week dose escalation to attain a daily 300 mg dose of Palforzia or placebo, followed by a six-month consistent dose period, concluding with an exit double-blind, placebo-controlled food challenge.
Stallergenes Greer International AG, headquartered in Baar, Switzerland, is a leading healthcare company focusing on diagnosing and treating respiratory, food, and venom allergies through allergen immunotherapy products and services.