Veltassa® Receives Approval in Japan for Potassium Control
Veltassa® Approved in Japan for Hyperkalemia Treatment
Veltassa® is a treatment designed for effective management of hyperkalemia, a condition marked by elevated potassium levels in the bloodstream. This innovative therapy has recently received approval from Japan’s Ministry of Health and Labor Welfare (MHLW), making it available for adult patients suffering from this serious health issue.
CSL Vifor has partnered with Zeria Pharmaceutical Co., Ltd., which will oversee the marketing of Veltassa® in Japan. This collaboration has yielded remarkable progress as Veltassa® has now been authorized for use in 41 countries globally.
Significance of Veltassa® in Managing Hyperkalemia
The approval of Veltassa® signifies a pivotal advancement in the management of hyperkalemia, particularly for patients grappling with chronic kidney disease and chronic heart failure. According to industry insights, it is estimated that over 300,000 individuals in Japan are affected by hyperkalemia. This new treatment option is crucial for providing effective and well-tolerated long-term potassium control for these patients.
“We are thrilled that Veltassa® is now available in Japan,” stated Hervé Gisserot, General Manager of CSL Vifor. “This milestone highlights our enduring dedication to meet the healthcare needs of patients facing hyperkalemia.” The appreciation expressed by CSL Vifor underscores the collaborative effort shared with Zeria and their commitment to improving patient outcomes.
Clinical Support and Future Plans
The approval was bolstered by substantial clinical data collected during the Japanese clinical development program of Veltassa®—designated as ZG-801. Clinical trials demonstrated the efficacy of this medication in controlling potassium levels among patients diagnosed with hyperkalemia.
In 2018, CSL Vifor facilitated the exclusive rights for Zeria to develop and market Veltassa® in Japan. Looking ahead, Zeria anticipates launching marketing operations for Veltassa® once the National Health Insurance price listing is established.
Understanding Hyperkalemia and Veltassa®
Hyperkalemia can lead to severe health consequences, with potassium levels exceeding the normal range of 3.5 to 5.0 mmol/L. While it may often present no symptoms, heightened potassium levels can escalate into severe conditions such as heart palpitations, chest pain, and nausea. Common underlying causes of hyperkalemia include chronic kidney disease and heart failure. Furthermore, certain heart medications can put patients at an increased risk for developing hyperkalemia.
Veltassa®, a sodium-free potassium binder, plays a vital role in effectively reducing potassium levels in patients. It functions within the gastrointestinal tract by facilitating the exchange of potassium for calcium, primarily in the colon. By expelling potassium through normal bodily functions, Veltassa® allows patients to maintain healthy potassium levels and remain on the necessary life-saving medications.
About CSL Vifor
CSL Vifor is a globally recognized pharmaceutical company specializing in providing innovative therapies, particularly for iron deficiency and nephrology. The company emphasizes strategic global partnerships to develop and market products aimed at enhancing patient care worldwide. Headquartered in St. Gallen, Switzerland, CSL Vifor is dedicated to crafting solutions that empower people to lead healthier lives.
The parent company, CSL (ASX: CSL; USOTC: CSLLY), is based in Melbourne and employs approximately 32,000 individuals, distributing lifesaving therapies to more than 100 countries.
Frequently Asked Questions
What is Veltassa® used for?
Veltassa® is utilized for managing hyperkalemia, a condition with elevated potassium levels in the blood.
Who will market Veltassa® in Japan?
Zeria Pharmaceutical Co., Ltd. has been granted the rights to market Veltassa® in Japan.
How does Veltassa® work?
Veltassa® works as a potassium binder, reducing potassium levels by exchanging potassium for calcium in the colon.
Why is managing hyperkalemia important?
Effective management of hyperkalemia is crucial to prevent severe health complications such as heart issues and other symptoms.
In how many countries is Veltassa® available?
Veltassa® has received marketing approval in 41 countries worldwide, enhancing access for patients.
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