FDA approves pediatric indication extension for Palforzia (arachis hypogaea) oral immunotherapy for treatment of peanut allergy – Stallergenes Greer

Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy, announced that the FDA has approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp], for the treatment of toddlers (ages 1-3 years) with a confirmed diagnosis of a peanut allergy.

This approval expands the January 2020 FDA approval for patients ages 4-17 years. Palforzia is to date the first and only approved oral immunotherapy treatment (OIT) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Peanut allergy currently affects approximately 2% of the general population of Western nations, and the prevalence of peanut allergy doubled among children between 2005 and 2015.

Compared with other food allergies, peanut allergy is associated with higher rates of accidental exposure, severe reactions and potentially fatal anaphylaxis. The difficulty in avoiding peanuts, combined with the severity of allergic reactions, shows the need for effective treatment.

“We are delighted that Palforzia has received regulatory approval in the U.S. for toddlers as there is a high unmet medical need for this age group and we are confident that this indication extension will alleviate the burden of peanut allergy for younger patients and their families,” says Elena Rizova, MD, PHD, Chief Medical Officer of Stallergenes Greer.

The FDA approval in toddlers is based on data from the Phase III POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study that was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia in peanut-allergic children aged 1 to 3 years old, meeting all its primary and secondary efficacy endpoints and demonstrating a favourable safety profile.

Stallergenes Greer acquired the rights to Palforzia in September 2023. As part of our ongoing commitment to delivering innovative solutions in allergen immunotherapy, our focus in the U.S has been on establishing a specialised Food Allergy business unit and transitioning the product into our AIT portfolio.