EU approves Itulazax for allergy to birch trees

ALK announced that it has successfully completed the marketing authorisation procedure for its tree sublingual allergy immunotherapy (SLIT) tablet in 17 European countries. Itulazax is expected to be the brand name of the tree SLIT-tablet. Itulazax is indicated in adult patients for the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis, induced by pollen from the birch homologous family of trees, which also includes alder, beech, hazel, hornbeam and oak. Itulazax is indicated in patients with a clinical history of symptoms despite use of symptom-relieving medication and a positive test of sensitisation to a member of the birch homologous group (skin prick test and/or specific IgE).

The data used in the filing were among the strongest pollen trial results ever seen in field studies of allergy immunotherapy. They include results from the Phase III clinical trial finalised in 2017 with Itulazax. Treatment with Itulazax reduced the total combined score (primary endpoint) by 40% compared to placebo. The effect was shown to be comparable across the entire birch, alder and hazel pollen season. Following today’s completion of the registration procedure, ALK expects the product to become available in the first European markets in Germany and Scandinavia within 2019.