Astellas Pharma and FibroGen have announced the receipt of approval from the Japan’s Ministry of Health, Labour and Welfare (MHLW) for Evrenzo (roxadustat) to treat anaemia in adult patients suffering from chronic kidney disease (CKD) but not on dialysis.
1n 2019, Astellas and FibroGen have also received Japanese approval for roxadustat for the treatment of anaemia in adult patients with CKD and on dialysis.
FibroGen now secures a milestone payment of $15m from Astellas, as the supplementary new drug application (sNDA) of roxadustat was approved in Japan.
CKD is defined by a progressive loss of kidney function due to damage of the kidneys, and is caused by conditions such as hypertension, diabetes or immune-regulated inflammatory conditions.
Roxadustat, which is a first-in-class orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH), enhances Hb levels through a mechanism of action that is different from that of traditional erythropoiesis-stimulating agents (ESAs).
The approval was based on data from three clinical studies, which evaluated more than 500 Japanese patients with anaemia of CKD not on dialysis.
According to the company, the first open-label phase 3 conversion study versus active comparator, darbepoetin alfa, achieved the primary efficacy endpoint of non-inferiority and continued to show maintenance of hemoglobin (Hb) levels over time.
The other two studies, including one phase 3 and one phase 2, also achieved the safety and efficacy of roxadustat in erythropoiesis-stimulating agent ESA-untreated patients, said the company.
As a HIF-PH inhibitor, roxadustat stimulates the body’s natural protective response to reduced oxygen levels in the blood. The response includes the regulation of multiple and coordinated processes that help to correct anaemia.
Astellas chief medical officer Dr Bernhardt Zeiher said: “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.
“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.”
Astellas and FibroGen have been collaborating to develop and commercialise roxadustat as a potential anaemia treatment in territories such as Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa.
FibroGen and AstraZeneca have partnered to develop and commercialise roxadustat as a potential anaemia treatment in the US, China and other markets in the Americas, as well as in Australia/New Zealand and Southeast Asia.
In October, Astellas Pharma secured fast track status from the US Food and Drug Administration (FDA) to develop ASP0367/MA-0211 (ASP0367) as a potential treatment for primary mitochondrial myopathies (PMM).