ALK's ITULAZAX® Approval Marks Progress in Allergy Treatment
ALK's Innovative ITULAZAX® Tablet Gains NICE Recommendation
ALK (ALKB:DC / OMX: ALK B) is thrilled to announce a significant advancement in allergy treatment with the National Institute for Health and Care Excellence (NICE) recommending the company’s tree pollen tablet, ITULAZAX®, for adult patients. This critical endorsement enables easier access through the National Health Service (NHS) systems in England, Wales, and Northern Ireland, making ITULAZAX® eligible for general reimbursement.
Milestones of Allergy Immunotherapy
The approval of ITULAZAX® marks a pivotal milestone for ALK, and it follows the recent NICE endorsement of ALK’s other sublingual allergy immunotherapy product, ACARIZAX®, earlier in the year. This makes ALK the first company to have two such products approved within a brief timeframe, showcasing its commitment to improving allergy treatment accessibility within the UK. By enhancing the options available for allergy treatments, especially for tree pollen allergies, ALK is addressing the significant gap in the underutilisation of allergy immunotherapy (AIT) across the UK compared to other European nations.
Understanding the Need for Effective Allergy Treatments
As tree pollen season approaches, experts warn that the warm weather is leading to an earlier onset and higher pollen counts. This poses challenges for the 16 million individuals in the UK suffering from hay fever, with about 4 million of them experiencing moderate to severe symptoms. While many people manage their hay fever with over-the-counter solutions, these measures may not suffice for those with more serious cases. ITULAZAX® promises an effective new option for those struggling with these challenges.
The Role of NICE in Healthcare Innovations
NICE plays a vital role in evaluating the clinical benefits and cost-effectiveness of health interventions. The organization released Final Draft Guidance for ITULAZAX® in July, emphasizing its potential benefits for patients struggling with uncontrolled tree pollen allergies. With the forthcoming publication of the Final Guidance, NHS systems will be required to integrate ITULAZAX® into their treatment protocols, thereby facilitating improved health outcomes for countless individuals.
Looking Ahead: ALK's Vision for Future Treatments
ALK's current focus within the UK includes its treatment for anaphylactic reactions through the adrenaline pen Jext® and the recently approved nasal spray EURneffy®, set to launch soon. While current sales of AIT tablets may be modest, ALK anticipates that integrating these products with its anaphylaxis treatments will foster long-term benefits as more patients learn about these valuable options. Furthermore, ALK is planning to expand submissions to include approvals for children, extending the positive impact of its innovative treatments.
It's important to note that the recommendation by NICE does not alter ALK’s financial outlook 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 allergies and allergy doctors. Headquartered in Hørsholm, Denmark, ALK employs around 2,800 people worldwide and is listed on Nasdaq Copenhagen. Discover more at www.alk.net.
Frequently Asked Questions
What is ITULAZAX®?
ITULAZAX® is a tree pollen tablet developed by ALK to treat allergies in adults, approved by NICE for use within the NHS.
How does ITULAZAX® work?
ITULAZAX® works by desensitizing the body's response to tree pollen, thereby reducing allergy symptoms through sublingual administration.
Why is the NICE recommendation significant?
The NICE recommendation is crucial as it facilitates patient access to effective treatment options, making therapy eligible for NHS reimbursement.
How prevalent is hay fever in the UK?
Approximately 16 million people in the UK suffer from hay fever, with about 4 million facing moderate to severe symptoms.
What is ALK's future vision for AIT products?
ALK aims to expand awareness and accessibility of its AIT products and plans to seek additional approvals for treating children with allergies.
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