Veltassa® Receives Approval in Japan for Treating Hyperkalemia
Veltassa provides reliable and well-tolerated long-term potassium management for patients with chronic kidney disease and heart failure.
Marketing Authorization Granted
CSL Vifor has announced that Japan's Ministry of Health, Labor and Welfare has approved its partner, Zeria Pharmaceutical Co., Ltd. (Zeria), to market Veltassa® for adults suffering from hyperkalemia. Hyperkalemia is a condition where potassium levels in the blood are too high, and Veltassa® is now authorized in 41 countries around the world.
Importance of This Approval
“We are thrilled that Veltassa® has been granted approval in Japan, and we want to congratulate our trusted partner Zeria,” said Hervé Gisserot, General Manager of CSL Vifor. This milestone reflects our shared commitment to meeting the needs of over 300,000 patients in Japan who are affected by hyperkalemia, especially those with chronic kidney disease or heart failure. This approval is a significant step forward in treating this serious condition.
Clinical Development Program
This approval comes after Zeria submitted their marketing authorization application, backed by promising clinical results from a development program in Japan for ZG-801 (Veltassa®) involving patients diagnosed with hyperkalemia.
Partnership and Future Plans
In 2018, CSL Vifor granted Zeria exclusive rights to develop and market Veltassa® in Japan. Zeria is planning to start the marketing process for Veltassa® after it receives pricing information from the National Health Insurance, ensuring that patients can access this treatment effectively.
What is Hyperkalemia?
Hyperkalemia is a serious medical condition marked by excessively high potassium levels in the bloodstream, which exceed the normal range of 3.5 to 5.0 mmol/L. This condition often doesn’t show symptoms, but if potassium levels elevate quickly, patients can experience severe symptoms such as heart palpitations, shortness of breath, chest pain, nausea, or vomiting.
Common Causes
The main causes of hyperkalemia often include chronic kidney disease and heart failure. Certain medications designed to help manage these conditions, particularly those targeting the renin-angiotensin aldosterone system, can also increase the risk of developing hyperkalemia.
About Veltassa®
Veltassa® acts as a sodium-free potassium binder that effectively lowers high potassium levels in the bloodstream while keeping them within normal ranges. The medication works in the gastrointestinal tract by swapping potassium for calcium in the colon, leading to the elimination of excess potassium from the body. This innovative mechanism allows patients to safely manage chronic hyperkalemia while continuing with essential doses of life-saving RAASi medications.
Clinical Evidence
Veltassa® has shown its effectiveness through various randomized, placebo-controlled trials, which support the optimal use of RAASi therapy for different patient groups. Currently, Veltassa® is recognized in 41 countries, including approvals in the U.S. and the European Union.
About CSL Vifor
CSL Vifor is dedicated to offering innovative therapies for iron deficiency and nephrology, securing its status as a leading global partner for pharmaceutical products. The company, based in St. Gallen, Switzerland, emphasizes strategic global partnerships aimed at enhancing the quality of life for patients worldwide.
Frequently Asked Questions
What is Veltassa® used for?
Veltassa® is prescribed for adult patients with hyperkalemia, helping lower their high potassium levels in the blood.
Who markets Veltassa® in Japan?
Zeria Pharmaceutical Co., Ltd. handles the marketing of Veltassa® in Japan after receiving approval.
How does Veltassa® work?
Veltassa® functions as a potassium binder, exchanging potassium for calcium in the gastrointestinal tract, which facilitates the removal of excess potassium.
What conditions lead to hyperkalemia?
Chronic kidney disease and heart failure are common conditions that can cause hyperkalemia.
In how many countries is Veltassa® approved?
Veltassa® has been granted marketing authorization in 41 countries, including both the U.S. and the European Union.
