Grenoble, France, 23rd April 2024 - Averoa, a biopharmaceutical company bringing innovative therapeutic solutions to people with renal diseases, announces the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for Ferric Citrate Coordination Complex (AVA1014), an oral iron-based compound for patients suffering from Chronic Kidney disease (CKD).

2024年4月23日，法国格勒诺布尔讯-为肾病患者提供创新治疗方案的生物制药公司Averoa宣布向欧洲药品管理局（EMA）提交柠檬酸铁配位复合物（AVA1014）的上市许可申请（MAA），这是一种用于慢性肾病（CKD）患者的口服铁基化合物。

Ferric Citrate Coordination Complex (AVA1014) was licensed from Akebia Therapeutics, Inc. (Akebia) in December 2022. Since then, Averoa has revised the clinical package and the regulatory strategy using all clinical studies and recent scientific publications to address the specific needs of the European market.

柠檬酸铁配位复合物（AVA1014）于2022年12月从Akebia Therapeutics，Inc.（Akebia）获得许可。从那时起，Averoa利用所有临床研究和最新科学出版物修订了临床方案和监管策略，以满足欧洲市场的特定需求。

The MAA submission is supported by three pivotal clinical studies performed by Akebia. The EMA will review the accepted application under the centralised marketing authorisation procedure and a decision on a potential approval is expected in 2025. This centralised procedure means that a single marketing authorisation application can be submitted to the European Union (EU), and, if approved, allows Averoa to market and make Ferric Citrate Coordination Complex (AVA1014) available to patients and healthcare professionals throughout the EU.

MAA的提交得到了Akebia进行的三项关键临床研究的支持。EMA将根据集中上市授权程序审查已接受的申请，预计2025年将做出潜在批准的决定。这种集中程序意味着可以向欧盟（EU）提交单一的上市授权申请，如果获得批准，则允许Averoa上市并向整个欧盟的患者和医疗保健专业人员提供柠檬酸铁配合物（AVA1014）。

“The submission of Averoa’s first product to the EMA is an exciting milestone as we seek to expand our portfolio of in-licenced products,” said Luc-André Granier, President and Medical Director at Averoa. “Patients with chronic kidney diseases are faced with a significant burden of disease requiring long-term treatment and there remains a high unmet need.” *** About CKDChronic Kidney Disease (CKD) describes the gradual loss of kidney function.

Averoa总裁兼医疗总监Luc AndréGranier表示：“Averoa的第一款产品提交给EMA是一个令人兴奋的里程碑，因为我们正在寻求扩大我们的授权产品组合。”。“慢性肾病患者面临着需要长期治疗的重大疾病负担，并且仍然存在很高的未满足需求。”***关于CKD慢性肾病（CKD）描述了肾功能的逐渐丧失。

It is a major public health problem resulting in an important burden for patients and healthcare system.

这是一个重大的公共卫生问题，给患者和医疗保健系统带来了重要负担。