Drug intelligence / Profile preview

allergenic extract of Betulaceae

Development stage
Unknown
Lead developer
Lofarma
Modality
Sublingual Immunotherapy → Allergy Immunotherapy → Therapeutic Vaccines → Vaccines & Immunotherapeutics, Subcutaneous Immunotherapy → Allergy Immunotherapy → Therapeutic Vaccines → Vaccines & Immunotherapeutics
Administration
Intradermal, Subcutaneous, Sublingual
01

Overview

The **allergenic extract of Betulaceae** is a standardized biologic product developed by the Italian pharmaceutical company **LOFARMA**. It is derived from the pollen of trees within the Betulaceae family, most notably birch (*Betula* species), and contains a complex mixture of allergenic proteins. The extract serves a dual purpose: it is used as a diagnostic reagent in skin prick testing (SPT) to identify sensitization in allergic individuals and as the active component in allergen immunotherapy (AIT) to treat respiratory allergies. Its mechanism of action involves the modulation of the IgE-mediated immune response; by interacting with allergen-specific IgE antibodies on mast cells and basophils, it can either trigger a diagnostic localized reaction or, through repeated therapeutic administration, induce long-term immune tolerance. The extract has been evaluated in Phase 2 clinical trials in Italy for biological standardization using histamine equivalent prick (HEP) units and the definition of in-house reference preparations (IHRP).

Other names
Betulaceae allergenic extractbirch pollen extractBetulaceae pollen extract
02

Targets

TCR (T cell antigen receptor complex)A. annua-specific IgE (Artemisia annua-specific immunoglobulin E)

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