Development and Regulatory status
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 .
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 .
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 .
Aug 18: Filed via the decentralised procedure for Allergic rhinoconjunctivitis, with Germany as the reference member state .
Sep 17: ALK-Abello intends to file in the EU and Canada in 2018 .
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 .