AVEROA收到欧洲药品管理局对XOANACYL®的积极意见，这是一种用于治疗慢性肾病（CKD）的口服疗法-动脉网

AVEROA Receives Positive Opinion from the European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease (CKD)

GlobeNewswire 等信源发布 2025-04-02 05:00

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CHMP recommends approval for XOANACYL, an oral therapy for use in the following therapeutic areas: Iron deficiency, chronic renal failure and hyperphosphatemia

CHMP建议批准XOANACYL，这是一种用于以下治疗领域的口服疗法：缺铁、慢性肾功能衰竭和高磷血症。

Final European Commission decision expected by June 2025; UK regulatory submission foreseen via MHRA’s international recognition procedure

预计欧盟委员会最终决定将于2025年6月作出；英国监管提交预计将通过MHRA的国际认可程序进行。

AVEROA seeking strategic commercial partners to bring XOANACYL to market across Europe

AVEROA 寻求战略商业伙伴，将 XOANACYL 推向欧洲市场。

Grenoble, France, April 2

法国格勒诺布尔，4月2日

, 2025

，2025

- Averoa, a biopharmaceutical company bringing innovative therapeutic solutions to people with renal diseases, today announces a positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for XOANACYL®, an oral therapy for chronic kidney disease (CKD).

- Averoa是一家为肾病患者提供创新治疗方案的生物制药公司，今天宣布欧洲药品管理局 (EMA) 人用医药产品委员会 (CHMP) 对用于治疗慢性肾病 (CKD) 的口服药物XOANACYL®发表了积极意见。

This milestone represents a key step toward a potential EU- approval..

这一里程碑标志着向潜在的欧盟批准迈出了关键一步。

XOANACYL (Ferric Citrate as Coordination Complex) is an oral therapy offering a dual mechanism of action for patients with CKD. This new treatment provides an effective source of ferric iron for addressing iron deficiency and plays a pivotal role in controlling phosphorus absorption. XOANACYL offers a comprehensive approach to improving patient outcomes in CKD..

XOANACYL（柠檬酸铁作为配位复合物）是一种口服疗法，为慢性肾病（CKD）患者提供双重作用机制。这种新疗法为解决缺铁问题提供了有效的三价铁来源，并在控制磷吸收方面发挥关键作用。XOANACYL为改善慢性肾病患者的治疗效果提供了全面的解决方案。

XOANACYL was licensed from Akebia Therapeutics, Inc. (Akebia) in December 2022. Since then, Averoa has created an appropriate dossier, in particular by re-engineering the clinical package, to support the dual indication for the benefit of the European patients.

XOANACYL于2022年12月从Akebia Therapeutics, Inc.（Akebia）获得许可。自那时以来，Averoa通过重新设计临床方案创建了适当的档案，以支持双重适应症，造福欧洲患者。

The marketing authorization application (MAA) was filed in March 2024 through the centralized European procedure, supported by three pivotal clinical studies performed by Akebia Therapeutics.

2024年3月，通过集中的欧洲程序提交了上市授权申请（MAA），该申请得到了Akebia Therapeutics进行的三项关键临床研究的支持。

The positive opinion will now be reviewed by the European Committee (EC), which has the authority to approve medicines for European Union member states. The EC has approximately two months from the CHMP opinion to issue the final decision. Additionally, Averoa will submit a marketing authorization application to the Medicines and Healthcare products Regulatory Agency (MHRA), following the international recognition procedure (IRP) which has the authority to approve medicines for the UK market.

积极的意见现在将由欧洲委员会（EC）审查，该委员会有权批准欧盟成员国的药品。EC在CHMP意见发布后大约两个月内做出最终决定。此外，Averoa将根据国际认可程序（IRP）向英国药品和健康产品管理局（MHRA）提交上市许可申请，该程序有权批准进入英国市场的药品。

A final MHRA decision is anticipated in the coming months..

预计MHRA的最终决定将在未来几个月内做出。

Luc-André Granier, President and Medical Director at Averoa, said

吕克-安德烈·格拉尼尔，Averoa的总裁兼医学总监表示

：

“This positive CHMP opinion is a pivotal moment for Averoa. It validates our ability to successfully navigate European regulatory pathways and brings us one step closer to offering a novel therapy to CKD patients. We are now focused on securing the right commercial partners to bring XOANACYL to market and accelerate patient access.” .

“这一积极的CHMP意见对Averoa来说是一个关键的时刻。它证明了我们成功驾驭欧洲监管路径的能力，并使我们更接近为慢性肾病患者提供一种创新疗法。我们现在正专注于寻找合适的商业伙伴，将XOANACYL推向市场并加速患者获得该药物。”

With EU approval expected in the coming months, Averoa is actively pursuing strategic commercial partnerships to support the launch and distribution of XOANACYL across Europe. The company is focused on collaboration models that can accelerate access to this innovative therapy and maximize its clinical and commercial impact..

预计将在未来几个月内获得欧盟的批准，Avero公司正积极寻求战略商业合作伙伴，以支持XOANACYL在欧洲的上市和分销。该公司专注于能够加速这一创新疗法的获取，并最大化其临床和商业影响的合作模式。

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About CKD

关于CKD

Chronic Kidney Disease (CKD) describes the gradual loss of kidney function. It is a major public health problem resulting in an important burden for patients and healthcare systems. It affects millions of people with an estimated prevalence ranging from 3% to 17% in Europe. It is one of the ten leading causes of death in developed countries and can be due to multiple causes, including: high blood pressure, diabetes, high cholesterol, kidney infections, glomerulonephritis, polycystic kidney disease, genetic conditions, autoimmune diseases, kidney stones, smoking, age, and use of certain medicines..

慢性肾脏病 (CKD) 描述了肾功能的逐渐丧失。它是一个主要的公共卫生问题，给患者和医疗系统带来了沉重的负担。在欧洲，数百万人受到影响，其估计患病率在 3% 至 17% 之间。它是发达国家十大死亡原因之一，可能由多种原因引起，包括：高血压、糖尿病、高胆固醇、肾脏感染、肾小球肾炎、多囊肾病、遗传条件、自身免疫疾病、肾结石、吸烟、年龄以及某些药物的使用。

CKD induces two common debilitating disorders, Iron Deficiency Anemia (IDA) and Mineral Bone Disorders (MBD) that in turn is linked to an increase of FGF23 as a compensatory mechanism. Depending on the stage of the disease, CKD can induce cardiovascular diseases. CKD can progress to end-stage kidney failure, which is fatal without dialysis or a kidney transplant..

慢性肾脏病（CKD）引发两种常见的衰弱性疾病：缺铁性贫血（IDA）和矿物质骨病（MBD），这些疾病反过来导致FGF23的增加作为一种代偿机制。根据疾病的阶段，CKD可能引发心血管疾病。CKD可能进展为终末期肾衰竭，若无透析或肾移植将是致命的。

About Xoanacyl

关于Xoanacyl

Akebia Therapeutics granted to Averoa an exclusive license to develop and commercialize Xoanacyl® in the European Economic Area, Turkey, Switzerland and the United Kingdom.

Akebia Therapeutics 授予 Averoa 在欧洲经济区、土耳其、瑞士和英国开发和商业化 Xoanacyl® 的独家许可。

Xoanacyl® has been approved and is being commercialized in different regions: in the United States (US) under the brand name Auryxia® (ferric citrate) by Akebia Therapeutics, Inc.; in Japan as Riona® (ferric citrate hydrate) by Japan Tobacco Inc.; in Taiwan as Nephoxil® by Panion & BF Biotech Inc.; and in South Korea as Nephoxil® by Kyowa Kirin Korea Co.

Xoanacyl® 已在不同地区获得批准并正在商业化：在美国（US）以品牌名 Auryxia®（柠檬酸铁）由 Akebia Therapeutics, Inc. 销售；在日本以 Riona®（柠檬酸铁水合物）由 Japan Tobacco Inc. 销售；在台湾以 Nephoxil® 由 Panion & BF Biotech Inc. 销售；在韩国以 Nephoxil® 由 Kyowa Kirin Korea Co. 销售。

Ltd..

有限公司。

About Averoa

关于阿韦罗亚

Averoa is a biopharmaceutical company, founded in December 2021, bringing innovative therapeutic solutions to people with renal diseases. Averoa’s goal is to build, advance and commercialize a strong pipeline of products to meet significant unmet medical needs of patients with kidney or metabolic diseases..

Averoa是一家生物制药公司，成立于2021年12月，为肾病患者提供创新的治疗方案。Averoa的目标是构建、推进和商业化一系列强大的产品管线，以满足肾病或代谢疾病患者显著未满足的医疗需求。

More information is available on our website

更多信息请访问我们的网站

www.averoa-pharma.org

and on our

并在我们的

LinkedIn page

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Contacts

联系人

：

Averoa