Danish-based pharmaceutical company Alk’s house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet Acarizax has secured approval for expansion in 12 European countries.
The product can be used in adolescent patients with HDM-induced allergic rhinitis.
The approval covers patients aged between 12 and 17 and is based upon data from clinical trials conducted in Japan and North America as part of the worldwide Acarizax clinical development programme in February this year.
This data led the global initiative for asthma (GINA), for the first time, to add allergy immunotherapy as a treatment option in its global strategy for asthma management and prevention.
Alk research and development executive vice-president Henrik Jacobi said: “This expanded approval is important for patients and important to Alk’s strategy for Acarizax.
“For patients, it means there can now be an earlier intervention to treat a condition that has far-reaching consequences for teenagers whose sleep, education and social lives are blighted by house dust mite allergy.”
Following the latest approval, the tablet can now be used in adolescents in Austria, the Czech Republic, Denmark, Finland, Italy, the Netherlands, Norway, Poland, Sweden, Slovakia, and the key European markets of France and Germany.
Initially, when Acarizax gained European approval for use in adults in 2015, it also became the first SLIT product to be approved for use in allergic asthma.
At present, the drug is approved in 17 countries worldwide and launched in nine countries.
Image: Alk’s production facilities in Hørsholm. Photo: courtesy of ALK-Abelló A/S.