ALK-Abello debuts its birch pollen allergy therapy in Germany
Key market for the new product
Danish drugmaker ALK-Abello has launched its tree pollen immunotherapy Itulazax in Germany, its first market, following its European approval earlier this year.
The sublingual allergy immunotherapy or ‘SLIT’ drug was cleared by the EMA in 17 countries for adults with moderate to severe allergic rhinitis and/or conjunctivitis caused by birch pollen, as well as other related tree species including alder, beech, hazel, hornbeam and oak.
It’s intended to be used in people who can’t control their symptoms using hay fever symptom-relieving medications, said the company. Birch trees are one of the most common causes of tree pollen allergy.
Tree pollen allergy is highly prevalent in northern Europe, so Germany is a key market for the new product, according to ALK-Abello, which already markets SLIT immunotherapies for house dust mite, grass, tree, ragweed and Japanese cedar allergies and says it now covers “all five major respiratory allergens.”
The company expects to roll Itulazax out next in Scandinavia – another birch pollen allergy hot spot – whilst also developing the product for the North American market.
“Tree pollen allergy is one of the world’s major respiratory allergies,” commented Søren Niegel, ALK’s head of commercial operations.
“The launch of Itulazax means that, for the first time, patients have access to a documented, registered sublingual tablet for their condition, which has shown unprecedented results in clinical trials,” he added.
The launch comes after a potential rival to Itulazax from UK-based Allergy Therapeutics flunked a phase 3 trial, setting the programme back by several months or more and giving ALK-Abello a sizeable lead in the market.
GlobalData said recently that the overall market for allergic rhinitis immunotherapies will reach $1.14bn by 2028, with the US and Japan contributing the lion’s share of growth based on uptake of grass pollen and cedar allergy products, respectively.
The market research firm says that in Europe products like Itulazax and grass pollen allergy products from ASIT Biotech (gp-ASIT) and Biomay (BM-32) will start to replace existing ‘named patient’ products but are unlikely to bring in new patients, pegging back sales growth.
继今年早些时候获得欧洲批准后，丹麦制药商 ALK-Abello 在德国推出了其树花粉免疫疗法 Itulazax，这是其首个市场。EMA 批准舌下过敏免疫疗法或“SLIT”药物在 17 个国家用于治疗桦树花粉引起的中度至重度过敏性鼻炎和/或结膜炎成人患者，以及其他相关树种，包括赤杨、山毛榉、榛树、角树和橡树。该公司说，它的目的是用于那些不能控制症状的人使用缓解花粉热症状的药物。桦树是引起树木花粉过敏的最常见原因之一。树花粉过敏症在北欧非常普遍，因此德国是新产品的关键市场，据 ALK-Abello 称，该公司已经销售了针对屋尘螨、草、树、豚草和日本雪松过敏症的狭缝式免疫疗法，并表示现在它涵盖了“所有 5 种主要的呼吸道过敏原。“该公司希望下一步在斯堪的纳维亚推出 Itulazax——另一个桦树花粉过敏热点——同时也为北美市场开发该产品。ALK 商业运营负责人 søren Niegel 评论道：“树花粉过敏是世界上主要的呼吸道过敏之一。”他补充说：“Itulazax 的上市意味着，患者首次可以获得针对其病情的有记录的、注册的舌下片剂，这在临床试验中显示了前所未有的结果。”总部位于英国的 Allergy Therapeutics 公司的 Itulazax 的潜在竞争对手在 3 期临床试验中失败后，ALK-Abello 的上市又被推迟了几个月甚至更长时间，这使得 ALK-Abello 在市场上占据了相当大的领先地位。GlobalData 近日表示，到 2028 年，过敏性鼻炎免疫疗法的整体市场将达到 11.4 亿美元，其中美国和日本分别贡献了基于摄取草花粉和雪松过敏产品的最大增长份额。市场研究公司表示，在欧洲，ASIT Biotech (gp-ASIT) 和 Biomay (BM-32) 的 Itulazax 和草花粉过敏产品将开始取代现有的“指定患者”产品，但不太可能带来新的患者，阻碍销售增长。
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