European Commission approves extended indication for Palforzia (defatted powder of Arachis hypogaea L semen (peanut)) for toddlers with a confirmed diagnosis of peanut allergy – Stallergenes Greer

Stallergenes Greer, a biopharmaceutical company specialising in allergen immunotherapy (AIT), announces that the European Commission (EC) has approved the extension of indication of Palforzia  (defatted powder of Arachis hypogaea L., semen (peanut)) for the treatment of toddlers (ages 1 through 3) with a confirmed diagnosis of peanut allergy. The marketing authorisation covers all 27 European member states and the three European Economic Area states (Iceland, Liechtenstein and Norway).

This approval of the extension of indication of Palforzia  to toddlers, follows the July 2024 approval by the FDA. Palforzia is the first and only EMA and FDA approved oral immunotherapy for toddlers with a confirmed diagnosis of peanut allergy.

“Peanut allergy is one of the most frequent food allergies. Early intervention is crucial to reduce the risks of accidental exposure and may be very important in improving long-term outcomes. The approval of Palforzia for toddlers represents for the medical community a meaningful advancement in managing allergy at a pivotal stage in a child’s development,” stated Dr Katharina Blümchen, Professor at the University of Medicine of Frankfurt, Clinic for Pediatric and Adolescent Medicine, Department of Pneumology, Allergology, Infectiology, and Gastroenterology.

“The approval of Palforzia  by the European Commission highlights the need for a treatment to help alleviate the burden of peanut allergy for young patients and their family,” said Michele Antonelli, CEO of Stallergenes Greer. “In addition to the risk of severe reactions from accidental exposure, peanut allergy can have significant psychological consequences on disease sufferers and their families while negatively impacting quality of life. We are proud of this milestone which highlights Stallergenes Greer’s commitment to the patients and healthcare professionals we serve