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爲慢性腎病和慢性心力衰竭患者1-5提供了有效和耐受的長期控制鉀的方案。
Zeria Pharmaceutical Co., Ltd. to market Veltassa in Japan
Zeria製藥將在日本市場推廣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日瑞士聖加倫- CSL Vifor 今天宣佈，日本厚生勞動省(MHLW)已爲其合作伙伴Zeria製藥株式會社(Zeria)授予了Veltassa在治療成人高血鉀症患者方面的上市授權批准。高血鉀是一種在血液中鉀含量高的情況。Veltassa已在全球41個國家獲得上市授權。
"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."
「我們很高興Veltassa在日本獲得批准，並祝賀我們值得信賴的合作伙伴Zeria，」 CSL Vifor的總經理Hervé Gisserot說。「這一里程碑反映了我們共同致力於解決日本超過30萬患有高血鉀症的患者的需求，尤其是那些患有慢性腎病或心力衰竭的患者。在我們繼續兌現承諾的同時，我們很高興推出下一代高血鉀管理療法，旨在廣泛應用於不同患者群體。」
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.
該批准是基於澤利亞提交的營銷授權申請，該申請得到了日本臨床開發項目 ZG-801（Veltassa）在日本高鉀血癥患者中的積極臨床數據支持。
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授予澤利亞在日本開發和市場 Veltassa 的獨家權利。澤利亞預計將在國民健康保險價格目錄公佈後開始銷售 Veltassa。
About CSL Vifor
關於 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 是全球藥品和創新領先療法（特別是鐵缺乏和腎病學方面）的首選合作伙伴。我們專門從事戰略全球合作伙伴關係、引入許可和開發、製造和營銷精準醫療藥品，旨在幫助全世界的患者過上更好、更健康的生活。總部設在瑞士聖加侖，CSL Vifor 還包括與費森尤斯醫療共同合資的患者腎病製藥公司 Vifor Fresenius Medical Care（與費森尤斯醫療合資）。
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, .
總公司 CSL（ASX: CSL; USOTC: CSLLY）總部位於澳大利亞墨爾本，在全球100多個國家擁有32,000名員工，並向這些國家的人們提供其拯救生命的治療方法。欲了解更多有關 CSL Vifor，請訪問。
About hyperkalemia
有關高鉀血癥
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.
高鉀血癥是一種嚴重疾病，指血液中的鉀含量超過正常水平（3.5至5.0毫摩爾/升）。通常，高鉀血癥是無症狀的。然而，當鉀水平非常高或者迅速增加時，人們可能會出現心悸、呼吸急促、胸痛、噁心或嘔吐的症狀。
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.
高鉀的最常見原因包括慢性腎病（CKD）和心力衰竭（HF）。用於延緩 HF 和 CKD 進展的藥物 - 腎素-抗腎上腺素醛固酮系統抑制劑（RAASi）- 也可能增加高鉀血癥的風險。
About Veltassa (patiromer)
關於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是一種無鈉交換鉀結合劑，能夠降低血液中過高的鉀含量，並維持鉀在正常水平。Veltassa通過在腸道內交換鉀和鈣的方式發揮作用，主要在結腸中。然後，鉀從體內通過正常排泄過程排出。Veltassa使患者能夠管理慢性高鉀血癥，使他們能夠保持在最佳和指南推薦的救命RAASi藥物劑量上。Veltassa已經通過一系列安慰劑對照的隨機臨床試驗，在各種患者群體中證明了其可以實現經過優化的RAASi治療使用。
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已在包括美國和歐盟在內的全球41個國家獲得批准。
References:
參考文獻：
|
1. |
Bakris GL, et al. JAMA 2015;314:151–61 |
|
2. |
Weir MR, et al. N Engl J Med 2015;372:211–21 |
|
3. |
Pitt B, et al. Eur Heart J 2011;32:820−8; |
|
4. |
Buysse J, et al. Future Cardiol 2012;8:17–28; |
|
5. |
Weir MR, et al. Am J Nephrol. 2024 Aug 19. |
|
6. |
Kashihara N, et al. Kidney Int Rep. 2019; 30;4(9):1248-1260 |
|
7. |
Montford JR, et al. J Am Soc Nephrol 2017;28(11):3155–65. |
|
8. |
Campese VM, et al. Kidney Int Suppl 2016;6(1):16–19. |
|
9. |
Cleveland Clinic. Hyperkalemia (High Potassium) available at: Date accessed: September 2024. |
|
10. |
Dunn JD, et al. Am J Manag Care 2015;21:S307–15. |
|
11. |
Agarwal R, et al. Lancet 2019;394:1540–50 |
|
1. |
Bakris GL等。JAMA 2015;314:151–61 |
|
2. |
Weir MR等人。新英格蘭醫學雜誌2015年;372:211-21 |
|
3. |
Pitt b等。eur心臟j 2011;32:820−8; |
|
4. |
Buysse J等。未來心臟病學 2012;8:17–28; |
|
5. |
Weir MR等。美國腎病學雜誌。2024年8月19日。 |
|
22億人民元（23年12月） |
Kashihara N等人。《腎臟國際報告》2019年;30;4(9):1248-1260 |
|
山東省 煙台市 経済技術開発區 |
Montford JR等人。J Am Soc Nephrol 2017;28(11):3155–65。 |
|
8. |
Campese Vm等人。Kidney Int Suppl 2016;6(1):16–19。 |
|
9. |
克利夫蘭診所。高鉀血癥（高鉀）可在以下網址找到： 訪問日期：2024年9月 |
|
10. |
Dunn JD等人。《美國管理保健》2015年;21: S307–15。 |
|
11. |
Agarwal R等人。《柳葉刀》2019;394:1540–50 |
CSL Vifor Media Contact
Thomas Hutter
+41 79 957 96 73
media@viforpharma.com
CSL Vifor媒體聯繫
Thomas Hutter
+41 79 957 96 73
media@viforpharma.com
譯文內容由第三人軟體翻譯。