Veltassa® (patiromer) approved in Japan for the treatment of adults with hyperkalemia

Rhea-AI Summary

CSL Vifor announced that Japan's Ministry of Health and Labor Welfare (MHLW) has approved Veltassa® (patiromer) for treating hyperkalemia in adult patients. This approval, granted to CSL Vifor's partner Zeria Pharmaceutical Co., , marks Veltassa®'s 41st country authorization worldwide.

Veltassa® offers effective long-term potassium control for patients with chronic kidney disease and chronic heart failure. The approval is based on positive clinical data from the Japanese development program of ZG-801 (Veltassa®).

This milestone addresses the needs of over 300,000 hyperkalemia patients in Japan. Zeria, which obtained exclusive rights to develop and market Veltassa® in Japan in 2018, plans to launch the product following National Health Insurance price listing.

Positive

• Veltassa® received approval in Japan for treating hyperkalemia in adults
• Veltassa® has now been authorized in 41 countries worldwide
• The approval addresses the needs of over 300,000 hyperkalemia patients in Japan
• Positive clinical data from the Japanese development program supported the approval

Negative

• None.

Veltassa^® offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients ^1-5

Zeria Pharmaceutical Co., Ltd. to market Veltassa^® in Japan

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.

"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."

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.

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.

About 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).

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.

About hyperkalemia

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}.

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.

About 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.

As of September 2024, Veltassa^® has been approved in 41 countries worldwide, including in the U.S. and the EU.

References:

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: https://my.clevelandclinic.org/health/diseases/15184-hyperkalemia-high-blood-potassium. 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

CSL Vifor Media Contact
Thomas Hutter
+41 79 957 96 73
media@viforpharma.com 

 

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SOURCE Vifor International AG (CSL Vifor)

FAQ

What is Veltassa® and what was it approved for in Japan?

Veltassa® (patiromer) is a medication that was approved in Japan for the treatment of hyperkalemia (high levels of potassium in the blood) in adult patients.

Who will market Veltassa® in Japan and when?

Zeria Pharmaceutical Co., will market Veltassa® in Japan. They plan to launch the product following National Health Insurance price listing.

How many countries has Veltassa® (CSLLY) been approved in globally?

Veltassa® has received marketing authorizations in 41 countries worldwide, including the recent approval in Japan.

What patient populations can benefit from Veltassa® in Japan?

Veltassa® can benefit over 300,000 patients in Japan affected by hyperkalemia, particularly those with chronic kidney disease or heart failure.