ALK-Abello debuts its birch pollen allergy therapy in Germany

Danish drugmaker ALK-Abello has launched its tree pollen immunotherapy Itulazax in Germany, its first market, following its European approval earlier this year.

The sublingual allergy immunotherapy or ‘SLIT’ drug was cleared by the EMA in 17 countries for adults with moderate to severe allergic rhinitis and/or conjunctivitis caused by birch pollen, as well as other related tree species including alder, beech, hazel, hornbeam and oak.

It’s intended to be used in people who can’t control their symptoms using hay fever symptom-relieving medications, said the company. Birch trees are one of the most common causes of tree pollen allergy.

Tree pollen allergy is highly prevalent in northern Europe, so Germany is a key market for the new product, according to ALK-Abello, which already markets SLIT immunotherapies for house dust mite, grass, tree, ragweed and Japanese cedar allergies and says it now covers “all five major respiratory allergens.”

The company expects to roll Itulazax out next in Scandinavia – another birch pollen allergy hot spot – whilst also developing the product for the North American market.

“Tree pollen allergy is one of the world’s major respiratory allergies,” commented Søren Niegel, ALK’s head of commercial operations.

“The launch of Itulazax means that, for the first time, patients have access to a documented, registered sublingual tablet for their condition, which has shown unprecedented results in clinical trials,” he added.

The launch comes after a potential rival to Itulazax from UK-based Allergy Therapeutics flunked a phase 3 trial, setting the programme back by several months or more and giving ALK-Abello a sizeable lead in the market.

GlobalData said recently that the overall market for allergic rhinitis immunotherapies will reach $1.14bn by 2028, with the US and Japan contributing the lion’s share of growth based on uptake of grass pollen and cedar allergy products, respectively.

The market research firm says that in Europe products like Itulazax and grass pollen allergy products from ASIT Biotech (gp-ASIT) and Biomay (BM-32) will start to replace existing ‘named patient’ products but are unlikely to bring in new patients, pegging back sales growth.