Japanese pharmaceutical firm Astellas, along with the biotechnology firm FibroGen, has submitted a supplemental New Drug Application (sNDA) to Japan’s Ministry of Health, Labour and Welfare, seeking marketing approval of Evrenzo (roxadustat).

Astellas said that its Evrenzo is indicated for the treatment of anaemia associated with chronic kidney disease (CKD) in non-dialysis dependent (NDD) patients.

Astellas chief medical officer Bernhardt G Zeiher said: “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.

“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.”

Astellas has conducted three clinical trials to support the regulatory approval

The drug has been approved in September 2019, for the treatment of anaemia associated with CKD in dialysis dependent (DD) patients in Japan and was launched in November 2019, with the same indication.

The company said that its sNDA of roxadustat for NDD-CKD patients is based on the results from three clinical trials conducted enrolling more than 500 Japanese patients.

The first clinical trial is an open-label Phase 3 conversion study of Evrenzo compared to darbepoetin alfa, which has reached its primary efficacy endpoint of non-inferiority and showed maintenance of haemoglobin (Hb) levels over time.

In addition, the study demonstrated that roxadustat was well tolerated, with a safety profile comparable to that of darbepoetin alfa.

The other two clinical trials are said to support the safety and efficacy of the drug in patients prone to erythropoiesis-stimulating agents (ESAs).

FibroGen Chief Medical Officer K Peony Yu said: “We are excited to reach another important milestone for roxadustat and appreciate the joint team’s commitment to addressing the significant unmet medical need of patients living with anaemia associated with CKD.”