Treatment for dialysis patients with CKD anaemia approved in Japan

FibroGen and Astellas Pharma Inc have announced that their treatment of anaemia associated with chronic kidney disease (CKD) in dialysis patients, Evrenzo^® (roxadustat), has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW).

“Evrenzo is a valuable new treatment option for dialysis patients with CKD anaemia,” said Bernhardt G Zeiher, MD, Chief Medical Officer, Astellas. “We are delighted to bring this important new treatment option to both patients suffering from, and healthcare professionals treating, this debilitating condition.”

Roxadustat is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl­ hydroxylase that corrects anaemia by a mechanism of action that is different from that of erythropoiesis-stimulating agents (ESAs).

As a HIF-PH inhibitor, roxadustat activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. The response activated by roxadustat involves the regulation of multiple, complementary processes to promote erythropoiesis and increase the blood’s oxygen-carrying capacity.

“With this approval in Japan, approval in China, and EU Marketing Authorisation Application (MAA) and US New Drug Application (NDA) preparations underway, we are another step closer to our goal of addressing the significant unmet medical need of patients living with anaemia of CKD, worldwide,” added said K Peony Yu, MD, Chief Medical Officer, FibroGen.

The approval is based on four Phase III studies conducted in CKD anaemia patients on dialysis in Japan. The studies demonstrated that roxadustat was effective at raising haemoglobin and that it was well-tolerated.

This marks the first approval for roxadustat through the Astellas and FibroGen collaboration.