First European Marketing Authorisation
The first specific immunotherapeutic agent for the treatment of food allergy has been authorised centrally for the entire European Union. The Paul-Ehrlich-Institut, acting as rapporteur, led the authorisation procedure.
On 17.12. 2020, the European Commission authorised the first immunotherapeutic agent for the treatment of allergies in a centralised procedure for the entire European Union (EU/EEA). This means that for the first time a therapeutic agent of proven quality, efficacy and safety is available for the treatment of a food allergy, in this case an allergy to peanuts.
The first central European marketing authorisation for a specific allergen-immunotherapeutic agent is an important step on the way to establishing standards for allergen products at a high level throughout Europe.
Prof. Vera Mahler , Head of the Allergology Division
In individuals who are allergic to peanuts, a small amount of peanut protein is often sufficient to trigger life-threatening symptoms, such as anaphylactic shock. Peanut-allergic individuals must therefore adhere to a strictly peanut-free diet and carry an adrenaline auto-injector pen with them at all times for the immediate treatment of severe allergic reactions. A peanut allergy often starts during childhood and, unlike most other food allergies, generally persists for the individuals entire life.
The allergen product Palforzia is indicated for the oral immunotherapy (OIT) of peanut allergy in children and adolescents between the ages of 4 and 17; if treatment is commenced at this age, it can be continued beyond the age of 18. A peanut-free diet must also be followed during treatment.
This immunotherapy, in which patients ingest a gradually increasing amount of allergen powder each day, must be directed by experienced medical personnel. The aim is to moderate the immune system's overreaction to the allergen, so that it gradually tolerates more peanut allergen. This reduces the risk of peanut-allergic persons experiencing severe symptoms if they accidentally ingest peanuts.
The Paul-Ehrlich-Institut is the only European marketing authorisation agency that has a division specialised in allergology. The allergy experts at the PEI, acting as rapporteur in the marketing authorisation procedure, led the assessment of the medicinal product.