European regulators have expanded the scope of ALK-Abello’s Acarizax to include the treatment of adolescent patients with house dust mite-induced allergic rhinitis.
House dust mites are the most common cause of allergy in the world, affecting 90 million people in Europe, North America and Japan, and more than 100 million in China.
The condition appears early in life and is present all year round, and nearly 50 percent of all house dust mite-allergic rhinitis patients suffer from concomitant asthma.
The expanded approval, which covers patients aged 12-17 years, is based upon data from clinical trials conducted in Japan and North America as part of the global Acarizax clinical development programme, which confirmed that the efficacy, safety and tolerability profile of the drug was in line with that seen in adult studies.
Commenting on the expanded approval, Henrik Jacobi, ALK’s executive vice president, R&D, said: “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.
“For ALK, it continues our strategy of widening patient access to evidence-based allergy immunotherapy (AIT) and of addressing unmet medical need."
Acarizax first gained European approval for use in adults in 2015, when it also became the first SLIT (sublingual allergy immunotherapy) to be approved for use in allergic asthma.
US regulators approved the drug for house-dust mite nasal inflammation (allergic rhinitis) back in March under the brand name Odactra.