Twelve European countries have expanded their approval of Danish firm ALK’s house dust mite (HDM) sublingual allergy immunotherapy (SLIT) Acarizax® to include therapy in adolescent patients aged 12 to 17 years. Acarizax was first approved in Europe in 2015 for treating adult patients with HDM allergy. Extended approval for adolescent patients has now been granted in France, Germany, Austria, the Czech Republic, Denmark, Finland, Italy, The Netherlands, Norway, Poland, Sweden, and Slovakia.
Henrik Jacobi, M.D., ALK’s evp for R&D, commented, “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 HDM allergy. For ALK, it continues our strategy of widening patient access to evidence-based allergy immunotherapy (AIT) and of addressing unmet medical need.”
Acarizax won FDA clearance last month for treating adult patients with HDM allergy-induced allergic rhinitis, with or without conjunctivitis. Approval of the drug in Japan, under the trademark Miticure™, was achieved by ALK’s Japanese partner Torii Pharmaceutical in September 2015. Torii submitted an application to the Japanese regulator last month for expanding the use of Miticure in pediatric patients.
ALK’s marketed portfolio and development pipeline includes tablet-based immunotherapies against grass, ragweed, HDM, Japanese cedar, and tree allergies. In February, the firm reported that a regulatory filing for its ragweed SLIT had been accepted for review in Europe. The ragweed immunotherapy, brand-named Ragwitek®, was approved by the FDA in 2014. Merck holds North American rights to the drug under license from ALK.