Veltassa® Receives Approval in Japan to Combat Hyperkalemia
Veltassa® Approved in Japan for Hyperkalemia Treatment
Veltassa offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients.
Marketing Authorization Granted
CSL Vifor has announced that Japan's Ministry of Health and Labor Welfare has granted its partner, Zeria Pharmaceutical Co., Ltd. (Zeria), marketing authorization approval for Veltassa® to treat adult patients with hyperkalemia. This condition is marked by elevated potassium levels in the blood and has now achieved marketing authorizations in 41 countries worldwide.
Significance of Approval
“We are delighted that Veltassa® has been approved in Japan, and we extend our congratulations to our trusted partner Zeria,” expressed Hervé Gisserot, General Manager of CSL Vifor. This achievement demonstrates a shared commitment to serve the needs of over 300,000 patients in Japan affected by hyperkalemia, particularly those suffering from chronic kidney disease or heart failure. The approval marks a significant advance in the therapeutic landscape for managing this condition.
Clinical Development Program
The approval was based on Zeria's filing of the marketing authorization application, which was bolstered by positive clinical findings from the Japanese development program for ZG-801 (Veltassa®) involving patients diagnosed with hyperkalemia.
Partnership and Future Plans
In 2018, CSL Vifor designated Zeria with exclusive rights to develop and market Veltassa® in Japan. Zeria anticipates initiating the marketing process for Veltassa® following the National Health Insurance price listing, paving the way for effective access for patients.
Understanding Hyperkalemia
Hyperkalemia is a critical medical condition characterized by an excess of potassium in the bloodstream, surpassing the normal level of 3.5 to 5.0 mmol/L. Often, hyperkalemia does not exhibit symptoms. However, when potassium levels soar or rise quickly, patients might face serious symptoms such as heart palpitations, shortness of breath, chest pain, nausea, or vomiting.
Common Causes
The most prevalent causes of hyperkalemia include chronic kidney disease and heart failure. Medications utilized to mitigate the progression of heart failure and chronic kidney disease, particularly renin-angiotensin aldosterone system inhibitors, may also elevate the risk of developing hyperkalemia.
About Veltassa®
Veltassa® functions as a sodium-free exchange potassium binder that effectively diminishes high potassium levels in the blood while maintaining normal levels. It operates within the gastrointestinal system by exchanging potassium for calcium in the colon, resulting in the excretion of potassium from the body. This unique mechanism allows patients to manage chronic hyperkalemia while remaining on essential and optimal doses of life-saving RAASi medications.
Clinical Evidence
Veltassa® has demonstrated its effectiveness across various randomized, placebo-controlled clinical trials, enabling optimized usage of RAASi therapy for diverse patient profiles. As of the present moment, Veltassa® is recognized in 41 countries, encompassing approvals in the U.S. and the European Union.
About CSL Vifor
CSL Vifor excels in providing innovative therapies in the areas of iron deficiency and nephrology, securing its position as a global partner of choice for pharmaceutical products. Based in St. Gallen, Switzerland, the company focuses on strategic global partnerships, including the development and marketing of pharmaceuticals that aim to improve patients' quality of life around the globe.
Frequently Asked Questions
What is Veltassa® used for?
Veltassa® is used to treat adult patients with hyperkalemia, helping to reduce high potassium levels in the blood.
Who markets Veltassa® in Japan?
Zeria Pharmaceutical Co., Ltd. is responsible for marketing Veltassa® in Japan following its approval.
How does Veltassa® work?
Veltassa® works as a potassium binder by exchanging potassium for calcium in the gastrointestinal tract, allowing for the excretion of excess potassium.
What conditions lead to hyperkalemia?
Conditions such as chronic kidney disease and heart failure are common causes of hyperkalemia.
In how many countries is Veltassa® approved?
Veltassa® has received marketing authorization in 41 countries globally, including the U.S. and EU.
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