Development and Regulatory status
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 .·