Core Viewpoint - ALK has received approval from Health Canada for ITULATEK, a tree pollen sublingual allergy immunotherapy tablet, for children and adolescents aged five to 17, expanding its treatment indications for moderate to severe seasonal allergic rhinitis in Canada [1][2]. Group 1: Product Approval and Market Impact - The approval of ITULATEK is expected to support market expansion in Canada, which is a key market for ALK's respiratory tablet portfolio, demonstrating solid double-digit growth [2]. - The tree pollen tablet is now indicated for treatment in children, adolescents, and adults aged five to 65 years in Canada, addressing allergies induced by birch, alder, hazel, and oak pollen [1][5]. Group 2: Clinical Trial and Safety Profile - The regulatory filing for ITULATEK was based on data from the TT-06 clinical trial, a Phase 3 trial involving 952 participants aged five to 17, which confirmed the treatment's favorable safety profile [4]. - The results of the TT-06 trial were published in the European Journal of Allergy and Clinical Immunology in 2024, indicating peer-reviewed validation of the treatment's efficacy and safety [4]. Group 3: Regulatory Landscape and Future Prospects - ITULATEK is currently approved in 22 countries for adults and has recently gained approval for children and adolescents in 17 EU countries, with ongoing pediatric regulatory reviews in Switzerland and the UK expected to complete in 2025 [5]. - With the extended label indications, ALK now has four tablets approved for children, adolescents, and adults, covering 80% of the most prevalent respiratory allergies in Europe and Canada [6].