On 15 October 2020, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) recommended the marketing authorisation of the first allergen immune therapeutic (Palforzia), which successfully underwent a Centralised Procedure. If its marketing authorisation is granted by the European Commission, it will be the first specific immune therapeutic against a food allergy, in this case peanut allergy, authorised in all EU/EEA countries. The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines evaluated the medicinal product as rapporteur in the marketing authorisation procedure.
A peanut allergy is particularly characterised by the fact that even extremely small amounts of peanut protein can be sufficient to cause life-threatening symptoms. For this reason, persons with peanut allergy must adhere to a strictly peanut-free diet and take an adrenalin autoinjector with them at all times to treat severe allergic reactions immediately. A peanut allergy often starts during childhood and, unlike other food allergies, usually persists life-long.
The immune therapeutic (Palforzia) is used as oral immune therapy (OIT) of the peanut allergy in children and adolescents (4 to 17 years) and is continued in patients who will turn 18 during their treatment. The patient receives the therapeutic while continuing to adhere to a peanut-free diet. The OIT which will be supervised by especially trained and experienced personnel aims at modifying the overreactive situation of the patients’ immune system. Through a gradual increase in the allergen uptake, the immune system will then be able to tolerate increased quantities of peanut allergen. That way, the probability of reacting with severe symptoms when peanuts are inadvertently consumed will decrease.
Updated: 26.10.2020
