BRIEF—ALK says Health Canada has approved Itulatek

Denmark-based allergy immunotherapy specialist ALK Abello today announced that Health Canada has approved once-daily Itulatek (standardized allergen extract, white birch [betula verrucose] sublingual tablet) for the treatment of tree pollen allergy.

The approval was based, in part, on data from a pivotal Phase III trial that evaluated the efficacy and safety of Itulatek in adult and adolescent patients with birch pollen allergic rhinitis and/or conjunctivitis.

Itulatek, the fourth once-daily sublingual allergy immunotherapy (SLIT)-tablet available in Canada from ALK, is indicated as an allergy immunotherapy for the treatment of moderate to severe seasonal allergic rhinitis, with or without conjunctivitis, induced by pollen from birch, alder, and/or hazel in adults 18 to 65 years of age who have a clinical history of symptoms of allergic rhinitis, despite use of symptom-relieving medication, and a positive test of sensitization to one or more of the pollen of birch, alder, or hazel (skin prick test and/or specific IgE).