13 / 2018
In August 2018, the first therapy allergens assessed in accordance with the Therapy Allergen Regulation received a marketing authorisation in Germany. They are authorised for the treatment of allergies against birch pollen and other early blossoming trees. The regulation, which came into force in 2008, provides the legal framework of ensuring quality, safety, and efficacy of therapy allergens for the treatment of frequently occurring allergies. Since many of these products are on the market as Named Patients Products, experts of the Paul-Ehrlich-Institut (PEI) have been making efforts, since 2005, to establish a regulation in order that quality, efficacy, and safety are evaluated as part of a marketing authorization procedure ending in a mandatory marketing authorization.
Allergies are a widespread disease among the population. Hay-fever alone (allergic rhinitis or rhino-conjunctivitis; allergic inflammation of the mucosae of the nose or the conjunctivae of the eye) affect ten to 25% of the population in the western world.
Although many authorised therapy allergens are available that can be used for the treatment of various allergies, therapy allergens for individual patients can also be produced based on a prescription in accordance with the German medicine laws. Such so-called "Named Patient Products" do not require a marketing authorisation and are therefore not subject to the control by the PEI with regard to quality, safety, and efficacy.
This ruling is designed to make therapy allergens available for allergies for which no major clinical studies as part of marketing authorisation procedures can be performed, such as rare allergens. Before the therapy allergen regulation came into force, no limitation existed on certain products so that manufacturers themselves could decide whether they would aim at a marketing authorisation or introduce therapy allergies – including common allergens – into the market as "Named Patient Products".
Experts of the PEI were extensively committed to preparing a legal regulation to ensure the quality, efficacy, and safety for therapy allergens for the treatment of common allergies used in Germany. Such frequent allergies include birch pollen, grass pollen, or house dust mite allergies. The PEI experts made a significant contribution to establishing the Therapy Allergen Regulation. It came into force in 2008.
The reason why it took another ten years after the coming into force of the regulation until the first available medicines subject to the Therapy Allergen Regulation original designed as named patient products received a marketing authorisation is tedious development process. To receive a marketing authorisation, the benefit/risk balance of various doses must first be assessed in clinical trials to determine a dose appropriate for the therapy. For the products which have now been authorised, this dose-finding study showed that a higher dose than the one previously available on the market led to a better result. Efficacy and safety of the treatment with this dose were then tested in a further clinical study. For therapy allergens targeted against pollen which occur only seasonally, proof of efficacy took respectively long.
"We are pleased that first marketing authorisations have been granted pursuant to the Therapy Allergen Regulation, and wish that many will follow in the interests of those patients affected by allergies,"
said Professor Stefan Vieths, vice president of the PEI who, up to January 2017, was the head of Division Allergology of the PEI.
Contact:
Paul-Ehrlich-Institut
Press Office
Telefon: +49 6103 77 1030
Email: presse@pei.de
Updated: 03.08.2018
