ALK's ACARIZAX® Receives EU Nod for Treating Children

ALK's ACARIZAX® Gains Approval in Europe for Young Children

ALK (Copenhagen: ALK B) has exciting news regarding its ACARIZAX® (house dust mite sublingual allergy immunotherapy tablet), which has recently received approval from European health authorities. This important milestone allows for the treatment of young children aged five to 11 across 21 EU countries. The company anticipates market introductions soon, with the largest launch happening in Germany.

Significant Research Underpinning the Approval

The foundation of this approval is built on groundbreaking research, particularly the results from the MT-12 clinical trial. This study was the largest ever conducted in pediatric allergy immunotherapy, involving 1,458 young participants from North America and Europe. The randomized, placebo-controlled trial evaluated the safety and efficacy of ACARIZAX® for children suffering from house dust mite-induced allergic rhinitis and conjunctivitis, along with those with asthma. The compelling results of this trial were recently featured in the well-respected journal, The Lancet Regional Health – Europe.

Response from ALK's Leadership

Henriette Mersebach, ALK’s Executive Vice President of R&D, shared her insights on the approval, stating, “Today, most children with allergies rely on treatments for symptom relief, such as antihistamines or steroids. Many still suffer from persistent symptoms and require effective treatments addressing the root causes of their allergies. House dust mite allergies often begin in childhood and are linked to an increased likelihood of developing allergic asthma. This approval is a pivotal moment for enhancing allergy care for children and aligns with ALK’s growth aspirations.”

The Rising Need for Allergy Treatments

Allergies are increasingly common among children, with estimates suggesting that over ten million children between the ages of five and 11 experience uncontrolled respiratory allergies. House dust mites are a prevalent trigger for these allergies and are closely associated with asthma, making effective treatment vital.

Introducing ACARIZAX® and Its Global Availability

In Europe, the house dust mite tablet is known as ACARIZAX®. It is also marketed globally; in the USA, it is called ODACTRA®, while in Japan, it is referred to as MITICURE™. Until now, Japan was the only country with approval for using the tablet in young children, where a significant number of treated patients are indeed youths. Now, the ACARIZAX® tablet is set to serve children aged five to 65 in Europe, subjected to proper clinical history and positive allergen test results, along with existing moderate to severe symptoms despite ongoing treatment with symptom-relief medications. The tablet is also approved for use in adults aged 18-65 with house dust mite-induced allergic asthma.

Future Considerations in Regulatory Approvals

ALK is not stopping here; a regulatory review for ACARIZAX® is ongoing with the US Food and Drug Administration. Additionally, a separate review process for ALK’s ITULAZAX® tree tablet is underway in Europe and Canada, focusing on pediatric use as well. These reviews are projected to conclude around 2025, promising the potential for expanded treatment options in the near future.

Contact Information

For more inquiries about this groundbreaking approval or the treatments, ALK provides several contact points for both media and investor relations. Per Plotnikof represents Investor Relations with contacts at +45 4574 7527 or +45 2261 2525. Additionally, for media inquiries, Maiken Riise Andersen is available at +45 5054 1434.

About ALK

ALK is a prominent global pharmaceutical company specializing in allergy and allergic asthma treatments. With its headquarters in Hørsholm, Denmark, it has around 2,900 employees worldwide and is listed on Nasdaq Copenhagen. ALK aims to improve the lives of those afflicted by allergies, providing a range of allergy immunotherapy (AIT) treatments and related services.

Frequently Asked Questions

What is ACARIZAX®?

ACARIZAX® is a sublingual allergy immunotherapy tablet designed to treat allergies caused by house dust mites in children and adults.

What are the age limits for ACARIZAX® treatment?

ACARIZAX® is approved for use in children aged five to 11 and adults between 18 and 65 years old with diagnosed allergies.

Where is ACARIZAX® approved for use?

ACARIZAX® has received approval in 21 EU countries and is also marketed in the USA and Japan under different names.

What is the significance of the MT-12 trial?

The MT-12 trial provided substantial evidence for the safety and efficacy of ACARIZAX® in children, forming the basis for its approval in Europe.

Who can I contact for more information about ALK's treatments?

For inquiries, you can contact Investor Relations, Per Plotnikof, at +45 4574 7527, or Media Representative, Maiken Riise Andersen, at +45 5054 1434.

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