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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 Aug 13, 2026 · SMC’s August decisions news release highlights Acarizax as the first targeted treatment option specifically for house dust mite allergy that may help patients who cannot control symptoms with current therapies, SMC said the same day Restriction and population Advice follows a full submission from ALK-Abello Ltd (SMC2885) Dec 12, 2024 · Danish allergy immunotherapy specialist ALK Abello 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 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 2 days ago · Acarizax news for pharma BD, investors, and market analysts tracking EMA developments in Europe & United Kingdom Approvals, clinical readouts,…Jun 8, 2023 · The HDM tablet is marketed as ACARIZAX ® in Europe and a number of international markets, as ODACTRA ® in the USA, and as MITICURE™ in Japan The trial achieved its primary endpoint with an improvement of 22% in the total combined rhinitis score (TCRS) compared to placebo treated patients Dec 12, 2024 · 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