ALK's ITULATEK® Approved for Young Patients in Canada
ALK today announced that Health Canada has granted approval for its ITULATEK® (a sublingual allergy immunotherapy tablet) to treat children and adolescents aged five to 17. This significant development allows the use of the tree pollen tablet for managing moderate to severe seasonal allergic rhinitis, with or without accompanying conjunctivitis, caused by pollen from birch, alder, hazel, and oak trees. This approval reflects ALK’s commitment to developing accessible allergy treatments for various age groups.
Growth and Potential in the Canadian Market
Canada represents an essential market for ALK, particularly for its respiratory tablet portfolio, which has shown impressive double-digit growth rates. With the newly extended label for ITULATEK®, the company anticipates further market expansion opportunities. Henriette Mersebach, Executive Vice President of R&D, emphasized the importance of this approval, stating, "We appreciate the Canadian approval and look forward to offering this important treatment option to children and adolescents affected by uncontrolled tree pollen-induced respiratory allergy." This progress underlines ALK’s ongoing mission to broaden access to their respiratory tablet products across different demographics.
Clinical Trial Insights and Approval Process
The approval of ITULATEK® was based on data from the comprehensive TT-06 clinical trial, which was randomized and placebo-controlled, involving 952 children and adolescents who had a documented history of moderate to severe allergic rhinitis or conjunctivitis due to pollen from birch trees and its relatives. The trial established that the treatment was well tolerated, demonstrating a promising safety profile. These findings have been peer-reviewed and published in a prestigious journal, highlighting the scientific backing for this crucial treatment option.
Global Reach of ITULATEK®
Currently, the tree pollen tablet, known as ITULAZAX® in Europe, is approved in 22 countries for adult patients aged 18 to 65. Following this recent approval, ITULATEK® is now also approved for treating children and adolescents in 17 EU countries. Additional pediatric regulatory assessments are ongoing in Switzerland and the UK, with reviews anticipated to conclude by 2025. This expansion not only showcases ALK's commitment to young patients but also its ambition to lead in the global allergy treatment market.
ALK’s Commitment to Allergy Treatments
The introduction of ITULATEK® adds to ALK’s existing portfolio, which now includes four tablets designed to cover 80% of the most prevalent respiratory allergies among children, adolescents, and adults in Europe and Canada. This holistic approach demonstrates ALK’s dedication to addressing the various needs of allergy sufferers, signifying a significant milestone in enhancing the quality of life for individuals impacted by respiratory allergies.
Despite these advancements, the new approvals will not impact ALK’s financial guidance for the upcoming years. This stability indicates strategic planning and robust expectations for the company’s growth trajectory in the allergy treatment sector.
Contact Information:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Maiken Riise Andersen, tel. +45 5054 1434
Frequently Asked Questions
What is ITULATEK® used for?
ITULATEK® is used to treat moderate to severe seasonal allergic rhinitis in children and adolescents caused by tree pollen.
Who is eligible to use ITULATEK®?
ITULATEK® is approved for children and adolescents aged five to 17, along with adults aged 18 to 65.
How does ITULATEK® work?
ITULATEK® works as a sublingual immunotherapy, helping to desensitize the immune system to allergens over time.
What is the significance of the recent approval in Canada?
The approval expands access to vital allergy treatments for younger patients, marking a significant advancement in ALK’s commitments.
Are there ongoing studies or approvals for ITULATEK®?
Yes, pediatric regulatory reviews are ongoing in Switzerland and the UK, set to conclude by 2025.
