EMA expands approval of Acarizax House Dust Mite sublingual allergy immunotherapy (SLIT) tablet for adolescent patients- ALK
ALK has announced that its house dust mite sublingual allergy immunotherapy (SLIT) tablet Acarizax has had its approval in 12 European countries expanded to include the treatment of adolescent patients with HDM-induced allergic rhinitis. The expanded approval, which covers patients who are aged 12-17, is based upon data from clinical trials conducted in Japan and North America as part of the global Acarizax clinical development programme. The results confirmed the favourable efficacy, safety and tolerability profile of Acarizax and were in line with previous studies in adults.
Comment: The FDA approved the Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet, from Merck Inc, earlier this year. The HDM SLIT-tablet is approved for use in adults 18 through 65 years of age. The HDM SLIT-tablet is marketed in Europe and Australia under the brand name ACARIZAX and in Japan as MITICURE.
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