Astellas gains added approval for Evrenzo in Japan

Japanese drug major Astellas Pharma (TYO: 4503) and FibroGen (Nasdaq: FGEN) today announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) approved Evrenzo (roxadustat) for the treatment of anemia of chronic kidney disease (CKD) in adult patients not on dialysis.

This marks the second approval in Japan for roxadustat through the Astellas and FibroGen collaboration, after the therapy was approved and launched for use in adult patients with anemia of CKD on dialysis last year.

“We are delighted roxadustat is now approved in Japan for adults with anemia of CKD not on dialysis, as it allows even more patients to access this important new treatment option,” said Dr Bernhardt Zeiher, chief medical officer of Astellas, adding: “With its novel mechanism of action and oral administration, we hope roxadustat will alleviate some of the burden associated with anemia of CKD prior to the initiation of dialysis and deliver meaningful improvements in the lives of these patients.”