Japan approves Astellas and FibroGen's Evrenzo for chronic kidney disease patients currently not receiving dialysis

Japan’s Ministry of Health, Labour and Welfare (MHLW) has passed approval for Astellas and FibroGen’s Evrenzo (roxadustat) in the treatment of anaemia of chronic kidney disease (CKD) in adult patients who are not currently receiving dialysis.

The MHLW reached the decision after reviewing Phase 3 data which demonstrated that the therapy met its main goal, proving non-inferior to the active comparator darbepoetin alfa with a consistent maintenance of haemoglobin levels over time. Evrenzo was also found to have a comparable safety and tolerability to darbepoetin alfa.

This is the pair’s second successful Japanese approval for the drug, which is already available in the country for the treatment of anaemia of CKD in adult patients on dialysis.

“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,” remarked Dr Bernhardt G Zeiher, Chief Medical Officer at Astellas. “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.”

With this approval, FibroGen is set to receive a milestone payment of $15 million from Atellas under the terms of their previously established development and commercialisation partnership.

Matt Fellows