FDA Approves Palforzia for Children Ages 1 to 3

With authorisation, the first oral immunotherapy medication for reducing allergic reactions—including anaphylaxis—has been made accessible.

Patients aged one to three who have a verified allergy to peanuts are included in the FDA’s expanded clearance for Palforzia. The medicine was first approved in January 2020 and was prescribed for kids between the ages of 4 and 17.

Elena Rizova, MD, PHD, chief medical officer of Stallergenes Greer, commented: “We are delighted that Palforzia has received regulatory approval in the US 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.”

The initial and sole licensed oral immunotherapy medication for reducing allergic reactions—including anaphylaxis—occursred by unintentional peanut exposure is called Palforzia. Data from the POSEIDON (NCT03211247 phase 3 study, which were published in the New England Journal of Medicine Evidence, served as the foundation for the clearance.