GREENFIELD, Ind.--(BUSINESS WIRE)--Today, Elanco Animal Health Incorporated (NYSE: ELAN) announced that the first shipments of Varenzin™-CA1 (molidustat oral suspension), conditionally approved by U.S. Food and Drug Administration (FDA) as the first and only treatment to control non-regenerative anemia in cats with chronic kidney disease (CKD), are shipping to veterinary clinics around the country.

格林菲尔德（Ind.）-（BUSINESS WIRE）-今天，Elanco Animal Health Incorporated（NYSE:ELAN）宣布Varenzin首次发货™-美国食品和药物管理局（FDA）有条件批准的CA1（molidustat口服混悬液）作为控制慢性肾病（CKD）猫的非再生性贫血的第一种也是唯一一种治疗方法，正在运送到全国各地的兽医诊所。

Anemia from CKD can dramatically affect a cat’s existence, making them lethargic, reducing their appetite, and even leading to a rapid heart rate and difficulty breathing in severe cases. According to the FDA, CKD-related anemia is a complication that often contributes to death or euthanasia of affected cats due to poor quality of life.i The challenges of current therapy to address this devastating condition often include inconvenient and extra-label use of a human drug..

来自CKD的贫血可以显着影响猫的存在，使它们昏昏欲睡，降低食欲，甚至在严重的情况下导致心率加快和呼吸困难。根据FDA的说法，CKD相关性贫血是一种并发症，由于生活质量差，常常导致受影响猫的死亡或安乐死。目前治疗应对这种破坏性疾病的挑战往往包括不方便和标签外使用人类毒品。。

“Varenzin-CA1 is the first drug to receive conditional approval for use in cats, providing access to a novel medicine for our feline companions suffering from nonregenerative anemia due to CKD,” said the FDA Center for Veterinary Medicine, upon conditionally approving the product. “Additionally, this is the first drug for cats under expanded conditional approval, a pathway to the marketplace that encourages development of innovative treatments and increases the options for treating animals with uncommon conditions, serious or life-threatening diseases, or diseases without existing or adequate therapies.”.

FDA兽医中心在有条件地批准该产品时表示：“Varenzin-CA1是第一种获得猫用有条件批准的药物，为我们因CKD而患有非再生性贫血的猫科同伴提供新药。”。“此外，这是猫在扩大的有条件批准下的第一种药物，这是通往市场的途径，鼓励开发创新疗法，并增加治疗不常见疾病，严重或危及生命的疾病或没有现有疾病或疾病的动物的选择。足够的疗法“。

CKD-related anemia stops cats’ bone marrow from producing enough red blood cells to replace the older or damaged red blood cells that are naturally removed from the blood, resulting in the inability for oxygen to be carried from the lungs throughout the body. CKD is common among mature and senior cats, occurring in about 15-30% of feline patients over 12 years old.

CKD相关性贫血阻止猫的骨髓产生足够的红细胞来替代天然从血液中去除的较老或受损的红细胞，导致氧气无法从整个身体的肺部携带。CKD在成熟和高级猫中很常见，在12岁以上的猫患者中约有15-30%发生CKD。

Anemia is a common finding in over half of all CKD-diagnosed cats.ii However, prior to Varenzin-CA1, less than one-third of anemic cats received treatment.iii This latest innovation from Elanco addresses an unmet need for this chronic condition in mature cats and furthers Elanco’s feline portfolio aimed at keeping cats healthy throughout their lives, especially as they age..

贫血是所有CKD诊断猫中超过一半的常见发现.ii然而，在Varenzin-CA1之前，只有不到三分之一的贫血猫接受了治疗.iii Elanco的这项最新创新解决了成熟猫对这种慢性病的未满足需求并进一步推动Elanco的猫类产品组合，旨在保持猫的一生健康，特别是随着年龄的增长。。

“Chronic kidney disease is not curable, so veterinarians and pet owners are focused on improving quality of life and slowing disease progression in affected cats,” said Dr. Melinda Wood, Specialty Consulting Veterinarian at Elanco. “Varenzin-CA1 is an innovative, needle-free oral suspension option for cats that can be given at-home – no in-clinic injections needed.

Elanco专业咨询兽医Melinda Wood博士说：“慢性肾脏疾病无法治愈，因此兽医和宠物主人致力于改善生活质量并减缓患病猫的疾病进展。”。“Varenzin-CA1是一种创新的无针口服混悬液，适用于可以在家中给药的猫-不需要临床注射。

This innovation sets a new standard of care for cats suffering from the debilitating effects of this disease. It represents a paradigm shift in the early-treatment of CKD-related anemia and helps CKD cats feel more like their feline selves.”.

这项创新为患有这种疾病的衰弱效应的猫设定了新的护理标准。它代表了CKD相关性贫血早期治疗的范式转变，并帮助CKD猫感觉更像他们的猫科动物。

In a series of studies, Varenzin-CA1 was shown to have a reasonable expectation of efficacy in managing anemia in CKD cats. By day 28, 50% of cats given Varenzin-CA1 had increased their red blood cell count, and by day 56, 75% of cats had increased their red blood cell count, improving the ability to deliver necessary oxygen and nutrients to their bodies..

在一系列研究中，Varenzin-CA1被证明在治疗CKD猫贫血方面具有合理的疗效预期。到第28天，给予Varenzin-CA1的猫中有50%增加了他们的红细胞计数，到第56天，75%的猫增加了他们的红细胞计数，提高了向他们的身体输送必要的氧气和营养的能力。。

As a leader in feline care, Elanco has focused on bringing cutting edge products, like Varenzin-CA1, to market, in an effort to address challenges for pet owners and veterinarians, while improving the wellbeing of pets. This latest technology adds to Elanco’s existing feline portfolio, including Elura® (capromorelin oral solution) for cats, the only FDA-approved treatment specifically designed for the management of weight loss in cats with CKD.

作为猫科动物护理的领导者，Elanco专注于将Varenzin-CA1等尖端产品推向市场，努力应对宠物主人和兽医的挑战，同时改善宠物的健康状况。这项最新技术增加了Elanco现有的猫类产品组合，包括用于猫的Elura®（capromorelin口服溶液），这是FDA批准的唯一专门用于治疗CKD猫体重减轻的治疗方法。

These products are helping to improve the lives of older cats and reducing the burden of care for their owners as they age..

这些产品有助于改善老年猫的生活，并随着年龄的增长减轻主人的照顾负担。。

“The bond with our pets only deepens over time,” says Dr. Wood. “Unfortunately, it’s not uncommon for aging cats to be diagnosed with conditions that steal their personalities and make it hard for their owners to provide ongoing care. Elanco is uniquely offering products to address these later-stage health challenges, so cat owners no longer have to accept a sub-optimal existence for their mature and senior pets.”.

伍德博士说：“与宠物的关系只会随着时间的推移而加深。”。“不幸的是，老年猫被诊断出患有窃取其个性并使其所有者难以提供持续护理的情况并不罕见.Elanco独特地提供产品来应对这些后期的健康挑战，因此猫主人不再需要为其成熟和高级宠物接受次优的存在“。

This conditional approval reinforces Elanco’s commitment to pioneering solutions in the underserved chronic disease state and feline market through a growing portfolio of treatment options. For more information, visit https://my.elanco.com/us/campaign/varenzin.

这种有条件的批准加强了Elanco通过不断增长的治疗方案组合，致力于在服务不足的慢性病状态和猫市场开创性解决方案。欲了解更多信息，请访问https://my.elanco.com/us/campaign/varenzin.

Varenzin-CA1 Indication

Varenzin-CA1适应症

Varenzin-CA1 is indicated for the control of nonregenerative anemia associated with chronic kidney disease (CKD) in cats.

Varenzin-CA1适用于控制与猫慢性肾脏病（CKD）相关的非再生性贫血。

Varenzin-CA1 Important Safety Information

Varenzin-CA1重要安全信息

For oral use in cats only. Keep this drug, including used syringes, out of reach of children. Wash hands immediately after use. In case of accidental ingestion, seek medical advice immediately. Women who are pregnant or may become pregnant should administer the product with caution. Varenzin-CA1 should not be administered to cats that are pregnant, lactating or intended for breeding or to cats with known hypersensitivity to molidustat.

仅用于猫的口服。将这种药物（包括用过的注射器）放在儿童无法接触的地方。使用后立即洗手。如果意外摄入，请立即就医。怀孕或可能怀孕的妇女应谨慎使用该产品。Varenzin-CA1不应用于怀孕，哺乳期或打算用于繁殖的猫或已知对molidustat过敏的猫。

Use with caution in cats with a history of seizures and in cats predisposed to thromboembolic disease. Hematocrit (HCT) or packed cell volume (PCV) levels should be monitored regularly as polycythemia may result from use of Varenzin-CA1. Varenzin-CA1 has not been evaluated in cats less than 1 year of age.

在有癫痫病史的猫和易患血栓栓塞性疾病的猫中谨慎使用。红细胞压积（HCT）或包装细胞体积（PCV）水平应定期监测，因为使用Varenzin-CA1可能导致红细胞增多症。Varenzin-CA1尚未在1岁以下的猫中进行评估。

The most common adverse reactions included vomiting, increases in systolic blood pressure and mild transient increase in serum potassium. Click here for full prescribing information..

最常见的不良反应包括呕吐，收缩压升高和血清钾轻度短暂升高。点击这里查看完整的处方信息。。

Elura Indication:

Elura指示：

Elura is indicated for management of weight loss in cats with chronic kidney disease.

Elura适用于治疗慢性肾病猫的体重减轻。

Elura Important Safety Information:

Elura重要安全信息：

For oral use in cats only. Do not use in cats that have a hypersensitivity to capromorelin or in cats with hypersomatotropism (acromegaly). Elura may increase serum glucose for several hours after dosing; use in cats with current or historical diabetes mellitus has not been evaluated and may not be appropriate.

仅用于猫的口服。不要用于对capromorelin过敏的猫或患有超嗜性（肢端肥大症）的猫。Elura可在给药后数小时增加血清葡萄糖；尚未对患有当前或历史糖尿病的猫进行评估，可能不合适。

Use with caution in cats that may have cardiac disease, severe dehydration or hepatic dysfunction. Elura has not been evaluated in cats younger than 5 months of age or in breeding, pregnant or lactating cats. The most common adverse reactions included vomiting, hypersalivation, inappetence, behavior change and lethargy.

在可能患有心脏病，严重脱水或肝功能障碍的猫中谨慎使用。尚未对5个月以下的猫或繁殖，怀孕或哺乳期猫进行Elura评估。最常见的不良反应包括呕吐，唾液分泌过多，食欲不振，行为改变和嗜睡。

Click here to see Elura product label for full prescribing information..

点击这里查看Elura产品标签以获取完整的处方信息。。

ABOUT ELANCO

关于ELANCO

Elanco Animal Health (NYSE: ELAN) 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 nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities.

Elanco动物健康（纽约州：ELAN）是动物健康领域的全球领导者，致力于创新和提供产品和服务，以预防和治疗农场动物和宠物的疾病，为农民，宠物所有者，兽医，利益相关者和社会创造价值。整个。拥有近70年的动物健康遗产，我们致力于帮助我们的客户改善动物护理中的健康状况，同时也对我们的当地和全球社区产生有意义的影响。

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

在Elanco，我们的愿景是食品和友谊丰富的生活，以及我们的可持续发展方法，Elanco健康目标™– 所有这些都是为了促进动物，人，地球和我们企业的健康。在www.elanco.com了解更多信息。。

i FDA Conditionally Approves First Drug for Anemia in Cats with Chronic Kidney Disease | FDA

我FDA有条件地批准第一种治疗慢性肾病猫贫血的药物| FDA

ii Chalhoub S, et al. Anemia of renal disease: what it is, what to do and what's new. J Feline Med Surg. 2011;13(9):629-40.

ii Chalhoub S等人。肾病贫血：它是什么，做什么和什么是新的。J Feline Med Surg。2011；13(9):629-40.

iii Boyd LM, et al. Survival in cats with naturally occurring chronic kidney disease (2000-2002). J Vet Intern Med. 2008;22:1111-17

iii Boyd LM，et al。自然发生慢性肾病的猫的生存（2000-2002）。J Vet Intern Med。2008；22:1111-17

Elura, Varenzin, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. @2023 Elanco or its affiliates.

Elura，Varenzin，Elanco和对角线标志是Elanco或其关联公司的商标@2023年Elanco或其附属公司。

PM-US-23-0888

PM-US-23-0888