Veltassa (Patiromer) Approved in Japan for the Treatment of Adults With Hyperkalemia
Veltassa (Patiromer) Approved in Japan for the Treatment of Adults With Hyperkalemia
"We are pleased that Veltassa has been approved in Veltassa offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients 1-5
Veltassa为慢性肾病和慢性心力衰竭患者1-5提供了有效和耐受的长期控制钾的方案。
Zeria Pharmaceutical Co., Ltd. to market Veltassa in Japan
Zeria制药将在日本市场推广Veltassa。
ST. GALLEN, Switzerland, Sept. 24, 2024 /PRNewswire/ -- CSL Vifor today announced that Japan's Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical Co., Ltd. (Zeria), marketing authorization approval for Veltassa for the treatment of adult patients with hyperkalemia, a condition characterized by high levels of potassium in the blood. Veltassa has now received marketing authorizations in 41 countries worldwide.
2024年9月24日瑞士圣加伦- CSL Vifor 今天宣布，日本厚生劳动省(MHLW)已为其合作伙伴Zeria制药株式会社(Zeria)授予了Veltassa在治疗成人高血钾症患者方面的上市授权批准。高血钾是一种在血液中钾含量高的情况。Veltassa已在全球41个国家获得上市授权。
"We are pleased that Veltassa has been approved in Japan, and congratulate our trusted partner Zeria," said Hervé Gisserot, General Manager of CSL Vifor. "This milestone reflects our shared commitment to addressing the needs of over 300,000 patients in Japan affected by hyperkalemia6, particularly those with chronic kidney disease or heart failure. As we continue to deliver on our promise, we are excited to introduce a next generation hyperkalemia management therapy, designed to be broadly utilized across diverse patient groups."
“我们很高兴Veltassa在日本获得批准，并祝贺我们值得信赖的合作伙伴Zeria，” CSL Vifor的总经理Hervé Gisserot说。“这一里程碑反映了我们共同致力于解决日本超过30万患有高血钾症的患者的需求，尤其是那些患有慢性肾病或心力衰竭的患者。在我们继续兑现承诺的同时，我们很高兴推出下一代高血钾管理疗法，旨在广泛应用于不同患者群体。”
The approval is based on the marketing authorization application filing by Zeria, which was supported by positive clinical data from the Japanese clinical development program of ZG-801 (Veltassa) conducted in patients with hyperkalemia in Japan.
该批准是基于泽利亚提交的营销授权申请，该申请得到了日本临床开发项目 ZG-801（Veltassa）在日本高钾血症患者中的积极临床数据支持。
In 2018, CSL Vifor granted Zeria the exclusive right to develop and market Veltassa in Japan. Zeria expects to begin to market Veltassa following National Health Insurance price listing.
2018年，CSL Vifor授予泽利亚在日本开发和市场 Veltassa 的独家权利。泽利亚预计将在国民健康保险价格目录公布后开始销售 Veltassa。
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. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
CSL Vifor 是全球药品和创新领先疗法（特别是铁缺乏和肾病学方面）的首选合作伙伴。我们专门从事战略全球合作伙伴关系、引入许可和开发、制造和营销精准医疗药品，旨在帮助全世界的患者过上更好、更健康的生活。总部设在瑞士圣加仑，CSL Vifor 还包括与费森尤斯医疗共同合资的患者肾病制药公司 Vifor Fresenius Medical Care（与费森尤斯医疗合资）。
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, .
总公司 CSL（ASX: CSL; USOTC: CSLLY）总部位于澳大利亚墨尔本，在全球100多个国家拥有32,000名员工，并向这些国家的人们提供其拯救生命的治疗方法。欲了解更多有关 CSL Vifor，请访问。
About hyperkalemia
有关高钾血症
Hyperkalemia is a serious condition in which the amount of potassium in the blood exceeds the normal level (between 3.5 and 5.0 mmol/L)7. Usually, hyperkalemia remains asymptomatic. However, when the levels of potassium are very high or increase rapidly, people may experience heart palpitations, shortness of breath, chest pain, nausea, or vomiting 8, 9.
高钾血症是一种严重疾病，指血液中的钾含量超过正常水平（3.5至5.0毫摩尔/升）。通常，高钾血症是无症状的。然而，当钾水平非常高或者迅速增加时，人们可能会出现心悸、呼吸急促、胸痛、恶心或呕吐的症状。
The most common causes of high potassium include chronic kidney disease (CKD) and heart failure (HF). Medications used to delay progression of HF and CKD – renin-angiotensin aldosterone system inhibitor (RAASi) – may as well increase the risk of hyperkalemia10.
高钾的最常见原因包括慢性肾病（CKD）和心力衰竭（HF）。用于延缓 HF 和 CKD 进展的药物 - 肾素-抗肾上腺素醛固酮系统抑制剂（RAASi）- 也可能增加高钾血症的风险。
About Veltassa (patiromer)
关于Veltassa（patiromer）
Veltassa is a sodium-free exchange potassium binder which reduces high amounts of potassium in the blood and maintains the potassium at a normal level. Veltassa acts within the gastrointestinal tract by exchanging potassium for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process. Veltassa enables patients to manage chronic hyperkalemia, permitting them to stay on optimal and guideline-recommended doses of life-saving RAASi medications. Veltassa has demonstrated to enable optimized RAASi therapy use across a range of placebo-controlled, randomized clinical trials in a variety of patient profiles 2,3,11.
Veltassa是一种无钠交换钾结合剂，能够降低血液中过高的钾含量，并维持钾在正常水平。Veltassa通过在肠道内交换钾和钙的方式发挥作用，主要在结肠中。然后，钾从体内通过正常排泄过程排出。Veltassa使患者能够管理慢性高钾血症，使他们能够保持在最佳和指南推荐的救命RAASi药物剂量上。Veltassa已经通过一系列安慰剂对照的随机临床试验，在各种患者群体中证明了其可以实现经过优化的RAASi治疗使用。
As of September 2024, Veltassa has been approved in 41 countries worldwide, including in the U.S. and the EU.
截至2024年9月，Veltassa已在包括美国和欧盟在内的全球41个国家获得批准。
References:
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