Japan approves Astellas and FibroGen’s Evrenzo for anaemia in dialysis patients
Astellas Pharma and FibroGen have revealed that their collaborative drug Evrenzo (roxadustat) has secured marketing authorisation in Japan for the treatment of anaemia associated with chronic kidney disease (CKD) in dialysis patients.
The drug was approved following a decision from Japan’s Ministry of Health, Labour and Welfare (MHLW) after reviewing data from four Phase 3 studies which showed that it was effective in raising haemoglobin in anaemia patients on dialysis, while proving itself to be well tolerated. The ruling marks the first approval for the drug through the Astellas and FibroGen partnership.
As a hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor, Evrenzo acts differently to erythropoiesis-stimulating agents (ESAs) by activating the body’s natural response to reduced blood oxygen levels to improve its oxygen carrying capacity.
“Evrenzo is a valuable new treatment option for dialysis patients with CKD anaemia,” said Dr Bernhardt G Zeiher, Chief Medical Officer at Astellas. “Astellas is committed to improving the health of people worldwide and expanding treatment options, especially within the dialysis community where there is high-unmet need. We are delighted to bring this important new treatment option to both patients suffering from, and healthcare professionals treating, this debilitating condition.”
Dr K Peony Yu, Chief Medical Officer at FibroGen, added: “We appreciate the commitment and focus of our partner Astellas as we work together to bring a new therapy to CKD anaemia patients on dialysis in Japan,” “With this approval in Japan, NDA approval in China, and EU MAA and US 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.”
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