ACARIZAX® approved in Europe for treatment of young children

ALK ( ALKB:DC / OMX: ALK B ) today 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 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.The data that formed the basis for the approval includes results from the largest-ever...

Hørsholm, 12/12/2024 (informazione.news - comunicati stampa - economia)

ALK ( ) today 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 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.

The data that formed the basis for the approval includes results from the largest-ever paediatric AIT Phase 3 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, .

ALK's Executive Vice President of R&D, Henriette Mersebach (MD), says: “

Globally, it is estimated that more than ten million children, aged five to 11, have uncontrolled respiratory allergies and the number is growing. House dust mites are a common cause of allergy and closely linked to asthma.

The house dust mite tablet is marketed as ACARIZAX in Europe and several international markets, as ODACTRA in the USA, and as MITICURE™ in Japan. Until now, the tablet has been approved for use in young children only in Japan, where the vast majority of patients receiving treatment are children. In Europe, the tablet is now approved for use in patients aged five to 65 diagnosed by clinical history and a positive test of house dust mite sensitisation (skin prick test and/or specific IgE blood test) with persistent moderate to severe house dust mite allergic rhinitis despite use of symptom-relieving medication. In addition, the tablet is approved for house dust mite-induced allergic asthma in patients aged 18-65.

A corresponding regulatory review is currently ongoing with the US Food and Drug Administration. Furthermore, a separate regulatory review of ALK's tree tablet ITULAZAX is ongoing in Europe and Canada, also for use in children. These reviews are expected to complete in 2025.

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