The European health authorities, EMA, has approved the allergy company ALK's tablet vaccine against tree pollen allergy in 17 European countries.
”It is a day of celebration at ALK in Hørsholm today. It is a new chapter with global perspectives, and it is a great helping hand for the many people who suffer when there is pollen from birch and other related trees in the air,” Henrik Jacobi, research director at ALK, said to MedWatch.
The new tablet vaccine has been given the trade name Itulazax and is approved for adults for the treatment of moderate to severe allergic rhinitis (hay fever, red) caused by allergens that cross-react with birch pollen allergens, which include, in addition to birch, alder, beech, hazel, hornbeam and oak.
With today's completion of the approval procedure, ALK expects that the tablet will be available in in Germany and Scandinavia this year once national marketing authorisations and price and subsidy agreements have been reached.
"It is our belief that the greatest growth potential lies in Northern Europe. But, having said that, the product also has the potential to become a growth driver elsewhere in and outside Europe. Both in the US and Canada tree pollen allergy is common," Henrik Jacobi said.
Strong Clinical Data
It is estimated that about 10 per cent of people with allergic rhinitis have an allergy that is not well controlled, even despite the use of symptom-relieving medication.
For many of them, Itulazax according to ALK will be a relevant treatment option that can improve the quality of life by treating the underlying cause of the allergy and not just the symptoms.
"It is the first tablet vaccine to treat allergic rhinitis caused by tree pollen, and it has shown some of the strongest clinical data ever seen in a large study of tablet-based allergy vaccination," Henrik Jacobi said.
“We saw a reduction of the total combined score by 40% when treated with Itulazax compared to placebo," he said.
In Europe, approx. 15 million people is allergic to tree pollen, and about every tenth has so bad symptoms that they find it difficult to maintain a proper everyday life. In Denmark, up to 400,000 Danes suffer from allergies to birch, hazel, olive trees or other trees, but only 3,400 are currently being vaccinated, according to figures from Medstat.
"Tree pollen allergy is one of the most common allergies in the northern hemisphere, so it is a global product that one can use in many parts of the world, and so it is very important for our entire tablet portfolio that we have shown such strong clinical data It is simply a good product," Henrik Jacobi said.
With four tablets on the European market ALK is able to cover the most common airway allergies in the world that is treatable with allergy vaccination.
"To ALK this approval means really, very much. It is the last step towards completing our portfolio of tablet-based vaccines against respiratory allergies at a global level that is easy and convenient to take,” the research director said.
Front runner on the tablet vaccines
In 2006 ALK started with a tablet vaccine against grass pollen. Since then more have been added, and in 2017, the company's great hope, Odactra, against house dust mite allergy was approved in the US.
Now the time has come to trees, where the existing treatment on the market is an injection at the doctors office every 6-8 weeks over three years. With the tablet from ALK patients only need to see the doctor once to start treatment, and then take one tablet a day for three years.
In the recently presented financial statements for 2018, one could read that it is in the tablet business that the growth potential truely lies. Sales of tablets thus increased by as much as 36 per cent during the period, while sales of traditional injection and drop-based vaccines decreased, as has been the case in recent quarters.
Currently, the tablet business in ALK constitutes approximately 26 per cent of total revenue.