Veltassa® (patiromer) Approved in Japan for Hyperkalemia Treatment

CSL Vifor announced that Japan's Ministry of Health and Labor Welfare (MHLW) has granted marketing authorization approval to their partner, Zeria Pharmaceutical Co., Ltd. (Zeria), for Veltassa® in Japan. This approval allows Veltassa® to be used for the treatment of adult patients with hyperkalemia, a condition characterized by elevated potassium levels in the blood. With this approval, Veltassa® has now secured marketing authorizations in 41 countries worldwide.

Hervé Gisserot, General Manager of CSL Vifor, expressed satisfaction with the approval and congratulated their partner, Zeria. He emphasized that this milestone demonstrates their collective commitment to addressing the needs of over 300,000 patients in Japan who suffer from hyperkalemia, particularly those with chronic kidney disease or heart failure. Gisserot highlighted the ongoing efforts to introduce advanced hyperkalemia management therapies that can be widely used across various patient demographics.

The MHLW's approval is based on the marketing authorization application submitted by Zeria, which was supported by positive clinical data from Zeria's Japanese clinical development program of ZG-801 (Veltassa®). This program involved patients with hyperkalemia in Japan, providing the necessary evidence for regulatory approval.

In 2018, CSL Vifor granted Zeria the exclusive rights to develop and market Veltassa® in Japan. Following the National Health Insurance price listing, Zeria plans to begin marketing Veltassa® to the Japanese market.

CSL Vifor, headquartered in St. Gallen, Switzerland, is a global partner specializing in pharmaceuticals and innovative therapies, particularly in the areas of iron deficiency and nephrology. The company focuses on strategic global partnerships, in-licensing, development, manufacturing, and marketing of pharmaceutical products aimed at improving patients' health worldwide. CSL Vifor operates in collaboration with Vifor Fresenius Medical Care Renal Pharma, a joint venture with Fresenius Medical Care. The parent company, CSL, is based in Melbourne, Australia, and employs 32,000 people, delivering life-saving therapies in over 100 countries.

Hyperkalemia is a serious medical condition where the potassium levels in the blood exceed the normal range of 3.5 to 5.0 mmol/L. While often asymptomatic, severe or rapidly increasing potassium levels can cause symptoms such as heart palpitations, shortness of breath, chest pain, nausea, or vomiting. The most common causes of hyperkalemia include chronic kidney disease (CKD) and heart failure (HF). Additionally, medications that slow the progression of HF and CKD, such as renin-angiotensin aldosterone system inhibitors (RAASi), can increase the risk of hyperkalemia.

Veltassa® (patiromer) is a sodium-free potassium binder that reduces high potassium levels in the blood and maintains them within the normal range. It works in the gastrointestinal tract by exchanging potassium for calcium, primarily in the colon, and the excess potassium is then excreted from the body. Veltassa® helps patients manage chronic hyperkalemia, allowing them to continue on optimal doses of life-saving RAASi medications. Its efficacy in optimizing RAASi therapy use has been demonstrated across various placebo-controlled, randomized clinical trials involving diverse patient profiles.

As of September 2024, Veltassa® has been approved in 41 countries worldwide, including the United States and the European Union.