FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Acarizax’s European Approvals Expanded to Include Adolescent Allergic Reactions to Dust Mites

April 21, 2017

Acarizax, an immunotherapy developed by ALK, has had its approval in 12 European countries expanded to include adolescent patients with allergenic rhinitis, or hay fever, caused by house dust mites.

Acarizax first gained European approval for adults in 2015, in allergic asthma. It is now approved for use in patients aged 12 to 17 in Austria, the Czech Republic, Denmark, Finland, Italy, the Netherlands, Norway, Poland, Sweden, Slovakia, France and Germany.

The expanded approval was based on data from clinical trials conducted in Japan and North America.

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