Hyperkalemia treatment approved in Japan

Japan’s Ministry of Health and Labor Welfare (MHLW) has granted CSL Vifor’s partner, Zeria Pharmaceutical Co Ltd, marketing authorisation approval for Veltassac for the treatment of adult patients with hyperkalemia, a condition characterised by high levels of potassium in the blood. Veltassa, a sodium-free exchange potassium binder which reduces high potassium levels, has now received marketing authorisations 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. “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 utilised across diverse patient groups.”

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

In 2018, CSL Vifor granted Zeria the exclusive right to develop and market Veltassa in Japan. Zeria expects to begin to market Veltassa following National Health Insurance price listing.

More information online.