[Immunotherapy of allergies: current status].

Area of Science:

• Immunology
• Allergology
• Regulatory Science

Background:

• Allergen immunotherapy (AIT) is the sole causal, disease-modifying therapy for allergies, addressing symptoms and progression.
• Current literature and regulatory developments from the Paul-Ehrlich-Institut inform AIT practices.
• A significant number of AIT products are approved or in development for various allergies.

Purpose of the Study:

• To provide an updated overview of allergen immunotherapy (AIT).
• To discuss immunological, regulatory, and practical aspects of AIT.
• To highlight recent regulatory developments and product statuses.

Main Methods:

• Review of current literature on allergen immunotherapy.
• Inclusion of recent conceptual regulatory developments from the Paul-Ehrlich-Institut.
• Analysis of approved and developing AIT products in Germany.

Main Results:

• Germany has 62 approved AIT products and 61 in development, totaling 123 products for common allergies like pollen, mites, and insect venom.
• Products utilize native or modified allergen extracts (allergoids) with various adjuvants and formulations.
• Official batch release testing applies to most products, excluding named patient products (NPPs).

Conclusions:

• There is a need for AIT product development specifically for children.
• Food allergens are in late-stage clinical trials, with a peanut allergy oral AIT product nearing marketing authorization.
• Continuous scientific and regulatory exchange is crucial for developing AIT products aligned with EU standards for early causal treatment.