Betula verrucosa

Unassigned

New Medicines

Allergic rhinoconjunctivitis

Information

New formulation
ALK-Abello
ALK-Abello

Development and Regulatory status

Phase III Clinical Trials
Recommended for approval (Positive opinion)
None

Jun 19: There is no information available to confirm that the UK is one of the 17 EU countries involved in the current MA procedure [7].


Jun 19: Following completion of the decentralised registration procedure, ALK expects the product to become available in the first European markets in Germany and Scandinavia within 2019, once national marketing authorisations and market access has been obtained [7].


Jun 19: ALK today announced that it has successfully completed the marketing authorisation procedure for its tree sublingual allergy immunotherapy (SLIT) tablet in 17 European countries [6].


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].