ALK Abello’s Acarizax approved in Europe

Danish allergy immunotherapy specialist ALK Abello (ALKB: DC) announced that its European regulatory filing for Acarizax (house dust mite sublingual allergy immunotherapy tablet) in young children aged five to 11 has been approved by the health authorities in 21 European Union (EU countries via a type II variation procedure.

The first market introductions, including in ALK’s largest market, Germany, are expected to follow over the coming months.

ALK noted that the data that formed the basis for the approval includes results from the largest-ever paediatric AIT Phase III clinical trial, MT-12, which involved 1,458 children in North America and Europe. MT-12 was a randomised, placebo-controlled trial investigating the efficacy and safety of Acarizax in children aged five to 11 with a clinical history of house dust mite-induced allergic rhinitis/conjunctivitis with or without asthma. The trial demonstrated efficacy and safety of the treatment in children, and the results were recently published in the reputable scientific journal, The Lancet Regional Health – Europe.