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 (defatted powder of Arachis hypogaea L., semen (peanuts)) to include the treatment of peanut allergies in toddlers aged 1 to 3 years. This decision, announced by Stallergenes Greer, positions Palforzia as a potential first-in-class oral immunotherapy for this young population within the European Union.
Palforzia is designed to gradually increase a patient's tolerance to peanuts through controlled exposure, reducing the risk of severe allergic reactions from accidental exposure. The CHMP's recommendation is based on data from the Phase 3 POSEIDON study, a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of Palforzia in peanut-allergic children aged 1 to 3 years across North America and Europe.
The POSEIDON study met all primary and secondary efficacy endpoints, demonstrating a favorable safety profile. Key findings from the study, published in the New England Journal of Medicine Evidence, supported the regulatory submission. The study involved a 22-week dose-escalation period, followed by a six-month maintenance phase at a 300mg daily dose of Palforzia or placebo. The primary efficacy endpoint was achieved by 67% of children receiving Palforzia compared with 33.5% in the placebo group, resulting in a risk difference of 33.4 percentage points.
"The positive recommendation of Palforzia marks a significant step forward for younger children with peanut allergy, as well as for their families," said Elena Rizova, Chief Medical Officer at Stallergenes Greer. "This milestone builds on Stallergenes Greer’s long-standing commitment to delivering innovative solutions for the benefit of allergy sufferers."
Regulatory Context and Future Steps
The CHMP recommendation is currently under review by the European Commission, which holds the authority to grant central marketing authorizations within the European Union. If approved, the marketing authorization would extend to all 27 European member states, as well as Iceland, Liechtenstein, and Norway.
The U.S. Food and Drug Administration (FDA) approved a similar extension of the Palforzia indication in July 2024, also based on the POSEIDON trial data. Palforzia is already approved in the EU, UK, and Switzerland for treating peanut allergies in patients aged 4 to 17, and can be continued in patients 18 and older in conjunction with a peanut-avoidant diet.
About Palforzia and Stallergenes Greer
Palforzia, initially developed by Aimmune Therapeutics and later acquired by Nestlé before being divested to Stallergenes Greer in September 2023, represents a significant advancement in oral immunotherapy for peanut allergies. Stallergenes Greer, headquartered in Baar, Switzerland, specializes in the diagnosis and treatment of respiratory, food, and venom allergies.
