ALK’s ITULAZAX® Pediatric Indication Review Accepted in Europe

ALK has announced that the European health authorities have accepted the regulatory filing for ITULAZAX®, a sublingual allergy immunotherapy (SLIT) tablet for young children. The review process is expected to take up to nine months, and if approved, the product could be introduced in European markets as early as the first half of 2025.

The regulatory submission is backed by data from a successful Phase 3 clinical trial involving 952 children in Canada and Europe. This trial was designed to evaluate the efficacy and safety of ITULAZAX® in children aged 5 to 17 who suffer from moderate to severe allergic rhinitis and conjunctivitis caused by pollen from birch trees and related species. The trial was randomized and placebo-controlled, confirming that ITULAZAX® led to a 22% improvement over placebo. The results were statistically significant, reinforcing the effectiveness of the treatment.

Henriette Mersebach, ALK’s Executive Vice President of Research and Development, expressed satisfaction with the acceptance of the registration application. She highlighted the robust and consistent results in children, which align with previous trial outcomes. Mersebach emphasized that this filing is a crucial step toward enhancing the medical treatment of children with tree pollen allergies and aligns with ALK’s long-term growth objectives.

Globally, more than 10 million children are estimated to suffer from uncontrolled respiratory allergies, with tree pollen being a significant contributor. In Europe, ITULAZAX® is already approved for use in adults aged 18-65. The potential expansion to include younger children could significantly impact the management of tree pollen allergies in this age group.

ALK-Abelló A/S, the company behind ITULAZAX®, is a global specialty pharmaceutical company focused on allergy and allergic asthma treatments. Headquartered in Hørsholm, Denmark, ALK employs about 2,800 people worldwide and is listed on Nasdaq Copenhagen. The company’s portfolio includes various allergy immunotherapy treatments and other products aimed at improving the lives of people with allergies.

This development represents a significant milestone for ALK, potentially expanding its market reach and solidifying its position as a leader in allergy treatment. The company continues to work closely with health authorities to bring effective treatments to patients and improve the quality of life for those suffering from allergies.

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