Elanco收到欧盟兽药产品委员会（CVMP）对Zenrelia（ilunocitinib）的积极意见-动脉网

Elanco Receives Positive Opinion on Zenrelia (ilunocitinib) from EU's Committee for Veterinary Medicinal Products (CVMP)

CISION 等信源发布 2025-06-13 04:17

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Company expects approval and product supply in market before the end of third quarter

公司预计将在第三季度末之前获得批准并在市场供应产品。

GREENFIELD, Ind.

印第安纳州格林菲尔德

，

June 12, 2025

2025年6月12日

/PRNewswire/ -- Elanco Animal Health Incorporated (NYSE:

/PRNewswire/ -- Elanco动物健康公司（纽约证券交易所代码：

ELAN

) announced today that Zenrelia™ (ilunocitinib) has been granted a positive opinion by the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP), paving the way for the product's marketing authorization in the European Union in the next 60 days.

）今天宣布，Zenrelia™（ilunocitinib）已获得欧洲药品管理局兽医药品委员会（CVMP）的积极意见，为该产品在未来60天内获得欧盟市场授权铺平了道路。

The positive opinion notes, 'The benefits of Zenrelia are its efficacy in the treatment of pruritus associated with allergic dermatitis in dogs, and the treatment of clinical manifestations of atopic dermatitis in dogs.' The CVMP recommended granting the marketing authorization based on the quality, safety and efficacy demonstrated in the data submitted and the favorable benefit-risk balance.

积极的意见指出，“Zenrelia 的益处在于其对治疗与狗过敏性皮炎相关的瘙痒症的有效性，以及对狗特应性皮炎临床表现的治疗。” CVMP 根据提交的数据中展示的质量、安全性和有效性，以及良好的效益-风险平衡，建议授予上市许可。

Elanco is pleased the label will be consistent with other markets outside .

Elanco 很高兴标签将与之外的其他市场保持一致。

the United States

美国

where the product has already been approved, once the European Commission adopts this recommendation.

一旦欧盟委员会采纳该建议，相关产品已经获得批准的地方。

'This milestone marks a significant advancement in the expansion of Zenrelia, Elanco's fastest globalized product with eight major regulatory approvals expected in just 18 months,' said Dr.

“这一里程碑标志着Zenrelia扩展的重要进展，Elanco最快实现全球化的產品，预计在短短18个月内获得八个主要监管批准，”博士说道。

Ellen de Brabander

艾伦·德·布拉邦дер

, Executive Vice President Innovation and Regulatory Affairs at Elanco. 'As part of the EU approval process, Elanco has done a head-to-head non-inferiority study versus the marketplace incumbent, and we are very pleased with the result. With millions of itchy dogs unable to find relief, we're excited to bring this new solution to veterinarians across the EU.'.

Elanco执行副总裁兼创新与监管事务主管。“作为欧盟批准程序的一部分，Elanco进行了与市场领先产品相对比的非劣效性研究，我们对结果感到非常满意。由于数百万只瘙痒的狗无法找到缓解方法，我们很高兴能将这一新解决方案带给欧盟各地的兽医。”

Elanco expects to launch the product shortly after receiving marketing authorization with supply in the marketplace before the end of third quarter. Zenrelia is already available in

Elanco预计在获得上市许可后不久将推出该产品，并在第三季度末之前在市场上供应。Zenrelia已经上市。

Brazil

巴西

，

Canada

加拿大

，

Japan

日本

and

和

the United States

美国

, and the company expects additional approvals in

，公司预计会获得更多的批准在

Australia

澳大利亚

and the

和

United Kingdom

英国

in 2025.

2025年。

The positive opinion will be published on the CVMP's website in the coming days at

积极的意见将在未来几天发布在CVMP的网站上。

https://www.ema.europa.eu/en/news

。

ABOUT ELANCO

关于礼蓝

Elanco Animal Health Incorporated (NYSE:

礼蓝动物保健公司（纽约证券交易所：

ELAN

宜兰

) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities.

）是全球动物健康领域的领导者，致力于创新并提供产品和服务，以预防和治疗农场动物及宠物的疾病，为农民、宠物主人、兽医、利益相关者和社会整体创造价值。凭借70年的动物健康传统，我们承诺打破界限、超越自我，帮助客户改善他们所照料动物的健康，同时对本地和全球社区产生积极影响。

At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at .

在Elanco，我们以“食物与陪伴丰富生命”这一愿景为驱动力，并依托我们的Elanco健康使命™可持续发展支柱——这一切旨在促进动物、人类、地球和我们企业的健康。欲了解更多信息，请访问。

www.elanco.com

。

Investor Contact:

投资者联系：

Tiffany Kanaga

蒂芙尼·卡纳加

(765) 740-0314

tiffany.kanaga@elancoah.com

蒂芙尼·卡纳加@elancoah.com

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