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ALK's partner, Torii, gains paediatric approval for the house dust mite SLIT-tablet in Japan
ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that its partner for Japan, Torii, has gained approval from the Japanese Ministry of Health, Labour and Welfare, to expand the use of ALK’s house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet MITICURE™ to include paediatric allergic rhinitis patients. MITICURE™, which is sold by ALK as ODACTRATM in the USA and ACARIZAX® elsewhere in the world, has been available in Japan since 2015 for adults and adolescents aged 12-64 who suffer from HDM-induced allergic rhinitis. The product has also been included on Japan’s National Health Insurance reimbursement list since 2015. Henrik Jacobi, ALK’s Executive Vice President, Research & Development, said: “Since its original launch, MITICURE™ has steadily been finding favour with prescribers, and latest market reports from Japan show that the uptake has now reached encouraging levels and that our partner Torii has clear market leadership. The addition of a paediatric indication extends this innovative treatment option to an important new patient population, children, for whom the long-term effects of respiratory allergy can be particularly damaging.” The application for paediatric use drew upon cinical data from a safety and efficacy trial involving approximately 400 patients aged 5-17 with HDM-induced allergic rhinitis. The randomised, multi-centre, placebo-controlled, double-blind, comparative trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in the ‘Total Combined Rhinitis Score’ compared with placebo, which showed that MITICURE™ reduced the symptoms of HDM-induced allergic rhinitis in children as well as reducing their use of other medications. The findings were in line with earlier data from trials involving older patients. Since MITICURE™ is already on the market in Japan, no new launch is necessary and the product becomes available for paediatric use with immediate effect.
ALK-Abelló A/S
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About the HDM SLIT-tablet
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