The FDA has approved Palforzia for use in children ages 1 through 3 years to include initiation of treatment, up-dosing and maintenance in individuals ages 1 through 3 years with a confirmed diagnosis of peanut allergy to mitigate allergic reactions — including anaphylaxis — that may occur with accidental exposure to peanuts.
Palforzia, an oral immunotherapy (OIT) drug developed for the treatment of peanut allergy, was approved by the US Food and Drug Administration (FDA) in 2020 for use in children 4-17 years of age.
By introducing minute quantities of peanut protein and gradually increasing the dose over time, the drug raises the exposure level of peanut allergen required to set off an allergic reaction, thus protecting the patient from inadvertent contact with peanuts.
Palforzia is not a cure for peanut allergy. Patients undergoing Palforzia treatment must continue to avoid peanuts in their diets except for precise maintenance doses as prescribed by their physician.
Said Elena Rizova, MD, PHD, Chief Medical Officer, Stallergenes Greer, the maker of Palforzia:
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.
