Betula verrucosa

Unassigned

New Medicines

Allergic rhinoconjunctivitis

Information

New formulation
ALK-Abello
ALK-Abello

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
None

Aug 18: Filed via the decentralised procedure for Allergic rhinoconjunctivitis, with Germany as the reference member state [5].


Sep 17: ALK-Abello intends to file in the EU and Canada in 2018 [4].

Category

Fast-dissolving sublingual tablet-based immunotherapy (SLIT) containing biological extracts of birch tree allergens for desensitisation. Taken for 3 years.
Most allergenic tree pollen in north, central and eastern Europe is the birch (Betula) pollen [1]. Overall prevalence of 23% in allergic rhinitis was identified among European adults in a population-based survey in Belgium, France, Germany, Italy, Spain, and the UK in 2001 [2]. Prevalence of rhinoconjuctivitis among adults in the UK in 2001 was about 15% [3]. ALK estimates 15 million Europeans have tree allergies of which 10% are not well controlled with conventional symptomatic medicines [4].
Allergic rhinoconjunctivitis
Sublingual

Trial or other data

Sep 17: PIII trial meets its primary endpoint of reduction in combined rhinoconjunctivitis symptom and deciation score (TT-04; EudraCT2015-004821-15). The trial assessed birch pollen allergy sublingual immunotherapy tablet (SQ tree SLIT) 12IU od in patients with moderate to severe allergic rhinoconjunctivitis induced by birch pollen. 634 patients (aged 12 - 64 years) were enrolled in Sweden, Denmark, Czech Republic, Finland, Germany, Poland and France [4].