Therapy Areas: AIDS & HIV
ALK-Abelló announces European approval for its tree SLIT-tablet for allergic rhinitis
10 June 2019 -

ALK Abello A/S (ALK)(CPH:ALKB), a specialty pharmaceutical company focused on allergy and allergic asthma, announced on Friday the successful completion of the marketing authorisation procedure for its tree sublingual allergy immunotherapy (SLIT) tablet in 17 European countries.

ITULAZAX is expected to be the brand name of the tree SLIT-tablet.

The company said ITULAZAX is indicated in adult patients for the treatment of moderate-to-severe allergic rhinitis and/or conjunctivitis, induced by pollen from the birch homologous family of trees, which also includes alder, beech, hazel, hornbeam and oak. ITULAZAX is indicated in patients with a clinical history of symptoms despite use of symptom-relieving medication and a positive test of sensitisation to a member of the birch homologous group (skin prick test and/or specific IgE).

According to the company, for the first time, patients in Europe will have access to an effective, well documented and fast-dissolving SLIT-tablet for tree pollen allergy with no special storage conditions and no updosing required.

Also, the data used in the filing was among the strongest pollen trial results ever seen in field studies of allergy immunotherapy. These include results from the phase III clinical trial finalised in 2017 with ITULAZAX. Treatment with ITULAZAX reduced the total combined score (primary endpoint) by 40% compared to placebo. The effect was shown to be comparable across the entire birch, alder and hazel pollen season.

With the completion of the registration procedure, ALK now expects the product to become available in the first European markets in Germany and Scandinavia within this year, once national marketing authorisations and market access has been obtained.

ITULAZAX is the fourth ALK SLIT-tablet approved in Europe, including GRAZAX (2006), ACARIZAX (2015) and RAGWIZAX (2017), covering the most common respiratory allergies treated with allergy immunotherapy globally.