Astellas is seeking Japanese approval for Evrenzo for treating anaemia associated with chronic kidney disease (CKD) in non-dialysis dependent (NDD) patients.
The company has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare to gain marketing approval of the treatment.
The sNDA is supported by three studies in more than 500 Japanese patients, which establish the profile within this group of patients.
The first, an open-label Phase 3 conversion study versus active comparator, darbepoetin alfa, met the primary efficacy endpoint of non-inferiority and continued to demonstrate maintenance of hemoglobin (Hb) levels over time.
Evrenzo (roxadustat) was well tolerated and the safety profile of roxadustat was comparable to that of darbepoetin alfa.
The other two studies (one Phase 3 and one Phase 2) supports the safety and efficacy in patients naïve to erythropoiesis-stimulating agents (ESAs).
“The data demonstrates that roxadustat is effective in increasing and maintaining Hb levels within the target range in patients with anaemia associated with CKD who are not on dialysis,” said Bernhardt G Zeiher, Chief Medical Officer of Astellas.
“This submission is an important next step to bringing roxadustat to even more patients with this condition in Japan, and this is particularly pertinent in the non-dialysis setting where many patients’ anaemia is currently not treated, or not treated to target.”