ALK (ALKB:DC / OMX: ALK B) today announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of the company’s tree pollen tablet ITULAZAX® for the treatment in adults. The recommendation allows for patients to gain access to ITULAZAX® through the National Health Service (NHS) systems in England, Wales, and Northern Ireland by making it eligible for general reimbursement.
The recommendation of ITULAZAX® is another significant milestone for ALK, marking the second NICE approval of ALK’s sublingual allergy immunotherapy (AIT) products received in 2025.
Being the first-ever of their kinds to become widely accessible through the National Health Service (NHS) systems, ACARIZAX® (final approval obtained in March 2025) and ITULAZAX® are now available treatment options to address the significant underutilisation of AIT in the UK compared to other European countries.
ALK’s Executive Vice President of Commercial Operations, Søren Niegel, says: “Today’s approval emphasises a remarkable achievement by ALK with now two of our sublingual allergy immunotherapy tablets being recommended by NICE within less than six months. We appreciate the endorsement from a highly respected institute like NICE which improves the treatment accessibility for patients impacted by allergy”.
Scientists warn that this year's tree pollen season has started early due to warm weather, leading to higher pollen counts. This is bad news for the approximately 16 million people who are affected by hay fever in the UK, and while many manage symptoms with over-the-counter medicines, the consequences can be more challenging for the 4 million people with moderate to severe tree pollen hay fever.
NICE conducts reviews to assess the clinical benefits and cost-effectiveness of healthcare interventions, treatments, and technologies. The institute published a Final Draft Guidance on 21 July 2025, appraising the clinical benefits and cost-effectiveness of ITULAZAX® in the treatment of uncontrolled tree pollen allergy. NICE is expected to publish a Final Guidance in August, after which the NHS systems in England, Wales and Northern Ireland are required to implement ITULAZAX® in the treatment practices. Following the approved applications of ACARIZAX® and ITULAZAX® for adults and adolescents, submissions will also be made to extend the approvals to include children as well as for the grass tablet GRAZAX®.
ALK’s current business in the UK mainly focuses on anaphylaxis (treatment of severe allergic reactions) with the adrenaline pen Jext® on the market and the recently approved nasal spray EURneffy® due for launch later this year. AIT tablet sales are currently modest, but ALK expects the combination of its anaphylaxis treatments and the tablets to create long-term synergies in parallel with an expanded infrastructure and as more patients become aware of these treatment options.
The NICE approval does not affect ALK’s financial guidance for 2025.
ALK-Abelló A/S
For further information please contact:
Investor Relations: Per Plotnikof, tel. +45 4574 7527, mobile +45 2261 2525
Media: Maiken Riise Andersen, tel. +45 5054 1434
About ALK
ALK is a global specialty pharmaceutical company focused on allergy and allergic asthma. It markets allergy immunotherapy treatments and other products and services for people with allergy and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Find more information at www.alk.net.
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- InvestorNews_21July25_ITULAZAX recommended by NICE
