Veltassa approved in Japan for hyperkalemia

CSL Vifor, a subsidiary of Australia’s CSL Limited (ASX: CSL), today announced that Japan’s Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical (TYO: 4559) marketing authorization approval for Veltassa (patiromer) for the treatment of adult patients with hyperkalemia, a condition characterized by high levels of potassium in the blood. Veltassa has now received marketing authorizations in 41 countries worldwide.

“We are pleased that Veltassa has been approved in Japan, and congratulate our trusted partner Zeria,” said Hervé Gisserot, general manager of CSL Vifor, adding: “This milestone reflects our shared commitment to addressing the needs of over 300,000 patients in Japan affected by hyperkalemia, particularly those with chronic kidney disease or heart failure. As we continue to deliver on our promise, we are excited to introduce a next generation hyperkalemia management therapy, designed to be broadly utilized across diverse patient groups.”

The approval is based on the marketing authorization application filing by Zeria, which was supported by positive clinical data from the Japanese clinical development program of ZG-801 (Veltassa) conducted in patients with hyperkalemia in Japan.