Swiss biopharmaceutical company Stallergenes Greer International AG announced on Thursday that the European Commission has approved the extension of Palforzia's indication to include toddlers (ages 1-3) with peanut allergy.
Palforzia is the first and only European Medicines Agency (EMA)-approved oral immunotherapy for peanut allergy in this age group.
This approval allows for earlier treatment initiation, potentially reducing the risk of severe allergic reactions in young children.
The decision follows approval by the US Food and Drug Administration (FDA) in July 2024.
Palforzia is designed to desensitise children to peanut through a gradual and supervised treatment regimen.
The approval was based on data from the POSEIDON study, which demonstrated the efficacy and safety of Palforzia in this age group.
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