ST. GALLEN, SWITZERLAND, March 19, 2024 /PRNewswire/ -- CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association (NYHA) class II/III to improve exercise capacity. Ferinject has now received marketing authorization in 87 countries worldwide.

瑞士圣加仑，2024年3月19日/PRNewswire/-CSL Vifor今天宣布，加拿大卫生部已授权Ferinject（羧基麦芽糖铁）静脉注射（IV）治疗一岁及以上的成人和儿科患者缺铁性贫血，因为口服铁制剂不耐受或无效，以及用于治疗成人心力衰竭患者的铁缺乏症和纽约心脏协会（NYHA）II/III级，以提高运动能力。Ferinject现已在全球87个国家获得上市授权。

Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age and children.

研究表明，在加拿大，缺铁率甚至比以前报道的还要高，在育龄妇女和儿童中尤其普遍。

'While iron deficiency and associated anemia are some of the most prevalent medical conditions on a global scale, it is easily diagnosed and treatable,' said Prof. Dr. Justin Ezekowitz, Director of Cardiovascular Research and Cardiologist at the University of Alberta, Canada. 'The news of a new treatment option tested in clinical trials is welcomed, given that oral irons may not be able to adequately deliver the desired outcomes for Canadian patients with heart failure impacted by iron deficiency.'

加拿大阿尔伯塔大学心血管研究主任兼心脏病专家贾斯汀·埃泽科维茨（JustinEzekowitz）教授说，虽然缺铁和相关贫血是全球范围内最普遍的疾病之一，但它很容易被诊断和治疗鉴于口服铁剂可能无法为受缺铁影响的加拿大心力衰竭患者提供所需的结果，因此欢迎在临床试验中测试新治疗方案的消息。”

Iron deficiency affects one in every two hospitalized patients with heart failure. Iron deficiency is often accompanied by reduced exercise tolerance and untreated iron deficiency may result in anemia and worsening NYHA class, with reduced quality of life and eventually increased risk of hospitalization.

缺铁会影响每两名住院心力衰竭患者中的一名。缺铁常伴有运动耐量降低，未经治疗的缺铁可能导致贫血和NYHA分级恶化，生活质量下降，最终住院风险增加。

'The approval by Health Canada marks an important step forward for the treatment of iron deficiency anemia as well as iron deficiency in heart failure and supports our promise to patients and public health,' said Dr. Vinicius Gomes de Lima, Head of Global Medical Affairs, CSL Vifor. 'We are confident that our now approved IV iron therapy can make a meaningful contribution to achieve key therapeutic goals in the treatment of these patients.'.

CSL Vifor全球医疗事务负责人Vinicius Gomes de Lima博士说：“加拿大卫生部的批准标志着在治疗缺铁性贫血和心力衰竭缺铁方面迈出了重要的一步，并支持了我们对患者和公共卫生的承诺。我们相信，我们现在批准的静脉注射铁疗法可以为实现这些患者治疗的关键治疗目标做出有意义的贡献。”

Marketing authorization in Canada is based on a comprehensive clinical data package and totality of evidence from CSL Vifor's cardiology studies. In Canada, Ferinject® is commercialized through CSL Behring Canada, Inc., with availability expected in the second half of 2024.

加拿大的上市授权基于全面的临床数据包和CSL Vifor心脏病学研究的全部证据。在加拿大，Ferinject®通过CSL Behring Canada，Inc.商业化，预计将于2024年下半年上市。

* The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms. Patients who have a slight or marked limitation of their physical activity due to fatigue, palpitation and/or dyspnea are considered to have class II or class III heart failure, respectively.9.

*纽约心脏协会功能分类被医疗保健专业人员用于根据患者症状的严重程度对患者的心力衰竭进行分类。由于疲劳，心悸和/或呼吸困难导致身体活动轻微或明显受限的患者分别被认为患有II级或III级心力衰竭。

About CSL Vifor

关于CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives.

CSL Vifor是缺铁和肾脏病药物和创新领先疗法的全球首选合作伙伴。我们专注于战略性全球合作，为精准医疗保健授权和开发、制造和营销药品，旨在帮助世界各地的患者过上更好、更健康的生活。

Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care)..

CSL Vifor总部位于瑞士圣加仑，还包括联合公司Vifor Fresenius Medical Care Renal Pharma（与Fresenius Medical Care）。

The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor, visit www.cslvifor.com.

母公司CSL（ASX:CSL；USOTC:CSLLY）总部位于澳大利亚墨尔本，拥有32000名员工，为100多个国家的人们提供救生治疗。有关CSL Vifor的更多信息，请访问www.cslvifor.com。

About Ferinject

关于Ferinject

Ferinject (ferric carboxymaltose) is an IV iron therapy with marketing authorization in 87 countries as of March 2024. Ferinject has historically delivered significant value to patients and healthcare systems which is based on extensive clinical data and more than 25 million patient years of exposure.

Ferinject（羧基麦芽糖铁）是一种IV铁疗法，截至2024年3月已在87个国家获得上市许可。Ferinject历史上为患者和医疗保健系统带来了巨大的价值，这是基于广泛的临床数据和超过2500万患者年的暴露。

In Canada, Ferinject is indicated for the treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not tolerated or are ineffective, as well as for the treatment of iron deficiency in adult patients with heart failure and NYHA class II/III to improve exercise capacity.

在加拿大，当口服铁制剂不耐受或无效时，Ferinject用于治疗一岁及以上的成人和儿科患者的缺铁性贫血，以及用于治疗成人心力衰竭患者的缺铁性贫血和NYHA II/III级，以提高运动能力。

The diagnosis of iron deficiency must be based on laboratory tests.2.

缺铁的诊断必须基于实验室检查。

For more information and a complete risk/benefit profile, please refer to the Product Monograph available here.

有关更多信息和完整的风险/收益概况，请参阅此处提供的产品专论。

About iron deficiency and associated anemia

关于缺铁和相关贫血

Iron plays a vital role in many bodily processes, including the production of red blood cells, effective heart and brain function, and the prevention of infection and illness. Without enough iron, the body is unable to function properly. Common symptoms include fatigue, dizziness, and shortness of breath.

铁在许多身体过程中起着至关重要的作用，包括红细胞的产生，有效的心脏和大脑功能，以及预防感染和疾病。没有足够的铁，身体就无法正常运作。常见症状包括疲劳、头晕和呼吸急促。

Iron deficiency and iron deficiency anemia are estimated to affect one in three people worldwide, yet despite the serious consequences and high prevalence, the conditions remain under-recognized..

据估计，缺铁和缺铁性贫血会影响全世界三分之一的人，尽管后果严重且患病率很高，但这种情况仍未得到公认。

The effects of iron deficiency differ from person to person but can be linked to an overall decline in general health and well-being. Iron deficiency and iron deficiency anemia can be debilitating, exacerbate an underlying chronic disease and lead to increased morbidity and mortality. Common symptoms include fatigue pale skin, brittle nails, craving non-food items such as dirt, clay and ice, and an inability to concentrate.

缺铁的影响因人而异，但可能与总体健康和福祉的整体下降有关。缺铁和缺铁性贫血会使人衰弱，加剧潜在的慢性疾病，并导致发病率和死亡率增加。常见症状包括疲劳皮肤苍白，指甲脆，渴望污垢，粘土和冰等非食物，以及无法集中注意力。

In children, iron deficiency anemia can significantly impair cognitive and motor development.

在儿童中，缺铁性贫血会严重损害认知和运动发育。

Multiple organizations, including the World Health Organization (WHO), UNICEF and the U.S. Agency for International Development (USAID) have called for a comprehensive anemia monitoring framework. Find more information on the global burden of anemia in the report published in the Lancet in July 2023: https://pubmed.ncbi.nlm.nih.gov/37536353/..

包括世界卫生组织（WHO）、联合国儿童基金会（UNICEF）和美国国际开发署（USAID）在内的多个组织呼吁建立一个全面的贫血监测框架。有关全球贫血负担的更多信息，请参阅2023年7月发表在《柳叶刀》上的报告：https://pubmed.ncbi.nlm.nih.gov/37536353/.