Stallergenes Greer, a leading biopharmaceutical company specializing in allergen immunotherapy (AIT), announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the extension of the indication for Palforzia® to include toddlers aged 1 to 3 years with a confirmed peanut allergy diagnosis. If approved by the European Commission, Palforzia® will become the first EMA-approved oral immunotherapy (OIT) for toddlers with peanut allergies.
Expanding Treatment to Younger Patients
Palforzia® is an oral immunotherapy designed to gradually increase the body’s tolerance to peanut allergens through a controlled process of dose escalation, up-dosing, and maintenance. This expanded indication would allow younger children to begin treatment earlier, reducing the risk of severe allergic reactions from accidental peanut exposure.
“This positive recommendation marks a significant advancement for younger children with peanut allergies and their families,” said Elena Rizova, Chief Medical Officer at Stallergenes Greer. “It underscores our commitment to delivering innovative solutions that benefit allergy sufferers.”
Regulatory Progress
The CHMP recommendation now awaits review by the European Commission, which grants central marketing authorizations for the European Union and the European Economic Area states, including Iceland, Liechtenstein, and Norway. If approved, the marketing authorization will encompass all 27 EU member states and the three EEA countries.
In the United States, the FDA approved the expanded use of Palforzia® for toddlers in July 2024, reflecting growing global recognition of the therapy’s potential.
Clinical Evidence Supporting Approval
The regulatory submission is supported by findings from the Phase 3 POSEIDON study (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization), published in the New England Journal of Medicine Evidence in 2023. The trial assessed the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years, meeting all primary and secondary efficacy endpoints and demonstrating a favorable safety profile.
Broader Access and Continued Innovation
Stallergenes Greer remains focused on expanding access to Palforzia® while maintaining a comprehensive portfolio of solutions for allergy sufferers. These include:
- Oral immunotherapy for food allergies
- Sublingual tablets and liquid formulations
- Subcutaneous therapies for respiratory and insect venom allergies
This milestone reinforces Stallergenes Greer’s role as a leader in allergen immunotherapy, committed to improving the lives of allergy patients worldwide.
