Astellas Pharma and FibroGen have submitted a supplemental new drug application (sNDA) to the Ministry of Health, Labour and Welfare in Japan seeking approval for Evrenzo (roxadustat) to treat anaemia.
The companies intend to provide the drug for anaemia in chronic kidney disease (CKD) patients who are non-dialysis dependent (NDD).
Roxadustat is an oral hypoxia-inducible factor (HIF) prolylhydroxylase (PH) inhibitor. It corrects anaemia via activation of a natural response that occurs in case of decreased oxygen levels in the blood.
Last September, Roxadustat received regulatory approval in Japan to treat CKD-related anaemia in dialysis-dependent (DD) patients, also approved in China for NDD as well as DD patients.
The sNDA includes data from three studies conducted in more than 500 Japanese patients, including an open-label Phase III conversion study that compared the drug to darbepoetin alfa.
Data showed that the trial met its primary efficacy endpoint of non-inferiority. Roxadustat was well-tolerated, and its safety profile was comparable to that of darbepoetin alfa.
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Astellas Pharma chief medical officer Bernhardt 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 Pharma and FibroGen are working together to develop roxadustat for anaemia in multiple markets, including Japan, the Commonwealth of Independent States, Europe, the Middle East and South Africa.
Meanwhile, FibroGen and AstraZeneca partnered to develop and commercialise the drug for anaemia in the US and China, among other markets.
Earlier this month, FDA approved Astellas’ sNDA for antifungal drug Mycamine.