ALK Advances Allergy Treatment for Children with ODACTRA® Approval

ALK’s ODACTRA® Approval: A Milestone in Allergy Treatment

ALK has recently celebrated a significant victory as the US Food and Drug Administration (FDA) approved their ODACTRA® tablet for young children suffering from house dust mite (HDM) allergy. This promising development marks a pivotal moment in addressing allergic rhinitis, both with and without conjunctivitis, for children aged five to eleven, in addition to older patients.

What is ODACTRA®?

ODACTRA® is an innovative allergy immunotherapy (AIT) tablet designed to dissolve under the tongue, offering relief from allergy symptoms while potentially reducing the need for other symptomatic medications. This not only helps alleviate discomfort but also supports children in enjoying a better quality of life.

Clinical Insights Behind the Approval

The FDA's endorsement of ODACTRA® is based on the results of the largest-ever pediatric AIT Phase 3 clinical trial, known as MT-12. This extensive study involved 1,460 children across North America and Europe. The outcomes demonstrated both the efficacy and safety of ODACTRA®, with the results published in the esteemed scientific journal, The Lancet Regional Health – Europe.

The Growing Need for Allergy Solutions

With over ten million children aged five to eleven facing uncontrolled respiratory allergies globally, the need for effective treatment options is more urgent than ever. House dust mites, frequently responsible for such allergies, are also closely associated with asthma, highlighting the importance of ODACTRA® as a therapeutic solution.

Market Positioning of ODACTRA®

In the United States, ALK markets its house dust mite allergy tablet under the name ODACTRA®, whereas in Europe and various international regions, the same product is known as ACARIZAX®, MITICURE™ in Japan, and Sensimune™ in India. While the product has already been available for use in young children in Europe and Japan, ongoing regulatory reviews may see this treatment become more widely accessible. Canada is currently reviewing the tablet, and reviews for ALK’s tree tablet ITULAZAX® for pediatric use are underway in Europe and Canada, expected to be completed in 2025.

ALK’s Commitment to Allergy Solutions

ALK’s Executive Vice President of R&D, Henriette Mersebach, expressed enthusiasm about the FDA approval, emphasizing the importance of providing life-changing treatment options for children experiencing troublesome allergic symptoms. This commitment aligns with ALK’s long-standing mission to develop evidence-based, innovative medicines and to expand their portfolio of respiratory tablets for all age groups.

Looking Forward

While this approval is a major step forward for ALK, it is not projected to significantly impact the company’s financial outlook for the upcoming years. As they continue to develop and expand their range of products, ALK remains dedicated to improving the lives of those affected by allergies.

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

Frequently Asked Questions

What is ODACTRA® used for?

ODACTRA® is an allergy immunotherapy tablet approved for treating house dust mite allergies in children aged five to eleven.

How does ODACTRA® work?

ODACTRA® dissolves under the tongue to reduce allergy symptoms and decrease reliance on other medications.

What is the significance of the FDA approval?

The FDA’s approval enables the use of ODACTRA® in a younger demographic, providing important treatment options for managing HDM allergies.

Is there ongoing research for other allergy treatments?

Yes, ALK is also reviewing other tablets for pediatric use, aimed at expanding its range of effective allergy treatments.

How many children are affected by respiratory allergies?

Globally, over ten million children in the age group of five to eleven suffer from uncontrolled respiratory allergies.

About The Author

Hello, I'm Thomas Cooper, a financial expert and writer passionate about helping people understand and navigate the financial world. Having a solid financial background and a lot of experience, my area of expertise is simplifying difficult financial ideas into useful, understandable guidance. My goal with my writings and blog entries is to provide you the information and resources you need to make wise financial choices.

I am thrilled to contribute my ideas and engage with a lively investor community at Investors Hangout, where I recently joined the team. My mission is to make finance interesting and approachable so you may take charge of your financial future. I appreciate you coming along on this path to success and financial knowledge.

Contact Thomas Cooper privately here. Or send an email with ATTN: Thomas Cooper as the subject to contact@investorshangout.com.

About Investors Hangout

Investors Hangout is a leading online stock forum for financial discussion and learning, offering a wide range of free tools and resources. It draws in traders of all levels, who exchange market knowledge, investigate trading tactics, and keep an eye on industry developments in real time. Featuring financial articles, stock message boards, quotes, charts, company profiles, and live news updates. Through cooperative learning and a wealth of informational resources, it helps users from novices creating their first portfolios to experts honing their techniques. Join Investors Hangout today: https://investorshangout.com/

The content of this article is based on factual, publicly available information and does not represent legal, financial, or investment advice. Investors Hangout does not offer financial advice, and the author is not a licensed financial advisor. Consult a qualified advisor before making any financial or investment decisions based on this article. This article should not be considered advice to purchase, sell, or hold any securities or other investments. If any of the material provided here is inaccurate, please contact us for corrections.