ALK announced that the National Institute for Health and Care Excellence (NICE) has recommended its tree pollen tablet ITULAZAX for treatment in adults, marking a significant milestone in addressing allergy treatment accessibility in the UK. The recommendation enables patients to access ITULAZAX through the National Health Service (NHS) systems in England, Wales, and Northern Ireland by making it eligible for general reimbursement.
This approval represents ALK's second NICE recommendation for sublingual allergy immunotherapy (AIT) products in 2025, following the approval of ACARIZAX in March. Both products are now the first-ever of their kinds to become widely accessible through NHS systems, addressing the significant underutilization of AIT in the UK compared to other European countries.
Clinical Need and Market Impact
The timing of this approval is particularly relevant as scientists warn that this year's tree pollen season has started early due to warm weather, leading to higher pollen counts. This development affects approximately 16 million people with hay fever in the UK, with 4 million experiencing moderate to severe tree pollen hay fever. While many patients manage symptoms with over-the-counter medicines, the consequences can be more challenging for those with severe allergies.
"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," said Søren Niegel, ALK's Executive Vice President of Commercial Operations. "We appreciate the endorsement from a highly respected institute like NICE which improves the treatment accessibility for patients impacted by allergy."
Regulatory Timeline and Implementation
NICE published Final Draft Guidance on July 21, 2025, appraising the clinical benefits and cost-effectiveness of ITULAZAX in treating uncontrolled tree pollen allergy. The institute is expected to publish Final Guidance in August, after which NHS systems in England, Wales and Northern Ireland are required to implement ITULAZAX in treatment practices.
Following the approved applications of ACARIZAX and ITULAZAX for adults and adolescents, ALK plans to submit applications to extend approvals to include children as well as for the grass tablet GRAZAX.
Strategic Business Implications
ALK's current UK business primarily focuses on anaphylaxis treatment with the adrenaline pen Jext on the market and the recently approved nasal spray EURneffy due for launch later this year. While AIT tablet sales are currently modest, ALK expects the combination of its anaphylaxis treatments and the tablets to create long-term synergies alongside expanded infrastructure as more patients become aware of these treatment options.
The company confirmed that the NICE approval does not affect ALK's financial guidance for 2025, indicating the recommendation was anticipated in current projections.
