ALK Abello’s European filing for Itulazax pediatric use accepted for review

Danish allergy immunotherapy specialist ALK Abello (ALKB: DC) today revealed that iis European regulatory filing for Itulazax (tree sublingual allergy immunotherapy [SLIT] tablet) in young children has been accepted for review by the relevant health authorities.

The company noted that the European regulatory review process is anticipated to take up to nine months so that, subject to approval, the first market introductions in Europe could take place from the first half of 2025.

The data used in the European filing include results from a successfully completed Phase III clinical trial involving 952 children in Canada and Europe. The trial was a Phase III randomized, placebo-controlled trial to study the efficacy and safety of Itulazax in children aged five to 17 with a clinical history of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch trees and other trees in the birch homologous group. The trial achieved its primary endpoint confirming an overall improvement of 22% compared to placebo. Results were highly statistically significant.