ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the European regulatory filing for ITULAZAX® (tree sublingual allergy immunotherapy (SLIT) tablet) in young children has been accepted for review by the relevant health authorities. The European regulatory review process is anticipated to take up to nine months so that, subject to approval, the first market introductions in Europe could take place from the first half of 2025.

ALK（ALKB:DC/OMX:ALK B/AKBLF）今天宣布，有关卫生部门已接受欧洲监管机构对幼儿ITULAZAX®（树舌下过敏免疫疗法（SLIT）片剂）的审查。欧洲监管审查过程预计需要长达9个月的时间，以便在获得批准的情况下，从2025年上半年开始在欧洲首次引入市场。

The data used in the European filing include results from a successfully completed Phase 3 clinical trial involving 952 children in Canada and Europe. The trial was a Phase 3, randomised, placebo-controlled trial to study the efficacy and safety of ITULAZAX® in children aged 5 to 17 with a clinical history of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch trees and other trees in the birch homologous group.

欧洲申请中使用的数据包括一项成功完成的3期临床试验的结果，该试验涉及加拿大和欧洲的952名儿童。该试验是一项3期随机安慰剂对照试验，旨在研究ITULAZAX®对5至17岁儿童的疗效和安全性，这些儿童有中度至重度过敏性鼻炎和/或结膜炎的临床病史，这些过敏性鼻炎和/或结膜炎是由桦树花粉和桦树同源组中的其他树木引起的。

The trial achieved its primary endpoint confirming an overall improvement of 22% compared to placebo. Results were highly statistically significant. ALK’s Executive Vice President of Research and Development, Henriette Mersebach, says: “I’m pleased that our registration application for ITULAZAX® for young children has been accepted for review, and we look forward to the dialogue with the European authorities.

该试验达到了其主要终点，与安慰剂相比，总体改善了22%。结果具有高度统计学意义。ALK负责研发的执行副总裁Henriette Mersebach表示：“我很高兴我们针对幼儿的ITULAZAX®注册申请已被接受审查，我们期待着与欧洲当局进行对话。

The results in children are robust and consistent with previous trial results and this filing represents an important step forward for our ability to transform the medical treatment of children with tree pollen allergy as well as for ALK’s long-term growth ambitions.” Globally, it is estimated that more than 10 million children have uncontrolled respiratory allergies, and the number is growing.

儿童的结果是稳健的，与之前的试验结果一致，这份文件代表了我们改变树花粉过敏儿童医疗的能力以及ALK的长期发展目标的重要一步。”在全球范围内，估计有1000多万儿童患有不受控制的呼吸道过敏，而且这个数字还在增加。

Tree pollen is a common cause of these uncontrolled allergies. In Europe, the ITULAZAX® tablet is curr.

树花粉是这些不受控制的过敏的常见原因。在欧洲，ITULAZAX®平板电脑是通用的。

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