Japan Approves Veltassa® for Treating Hyperkalemia in Adults with Chronic Kidney Disease and Heart Failure

CSL Vifor and Zeria Pharmaceutical Co., Ltd. have announced that Japan's Ministry of Health and Labor Welfare (MHLW) has approved Veltassa® (patiromer) for the treatment of hyperkalemia in adults. Hyperkalemia is a condition characterized by elevated potassium levels in the blood, which can pose serious health risks, particularly for individuals with chronic kidney disease (CKD) or heart failure (HF).

Veltassa®, a long-term potassium binder that helps manage potassium levels effectively and is well-tolerated, has already received approvals in 41 countries, including the U.S. and Europe. This latest approval in Japan will be a crucial addition for the over 300,000 Japanese patients suffering from hyperkalemia, often exacerbated by medications used to treat CKD and HF, such as renin-angiotensin-aldosterone system inhibitors (RAASi).

Zeria Pharmaceutical will handle the marketing of Veltassa® in Japan, with sales expected to commence following National Health Insurance price listing. The approval is based on positive clinical data from Japanese trials conducted by Zeria.

Hervé Gisserot, General Manager of CSL Vifor, praised Zeria for its efforts in bringing Veltassa® to Japan, calling it a milestone in addressing the growing needs of patients. He emphasized the importance of this new therapy for diverse patient groups and the potential for hyperkalemia management to prevent further complications from CKD and HF.

Veltassa® works by binding potassium in the colon and helping the body excrete it naturally, making it a critical therapy for patients requiring consistent potassium control without compromising their ongoing treatment regimens.

With this approval, both CSL Vifor and Zeria Pharmaceutical look forward to further expanding Veltassa®'s reach and enhancing the lives of hyperkalemia patients globally.