Roxadustat approval – Astellas Pharma and FibroGen have secured approval for EVRENZO (roxadustat) in Japan for the treatment of anemia associated with chronic kidney disease (CKD) in adults, who are not on dialysis.
The approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) is the second in the country for roxadustat through the collaboration between Astellas Pharma and FibroGen.
Last year, roxadustat was approved in Japan and launched for use in adults with anemia of CKD on dialysis.
Bernhardt G. Zeiher – Chief Medical Officer of Astellas Pharma, commenting on the extended Roxadustat approval, 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.”
The extended roxadustat approval is based on results seen in three clinical studies in 500 plus Japanese patients with anemia of CKD not on dialysis.
One of the studies is a phase 3 conversion study of the drug in comparison to active comparator, darbepoetin alfa. The late-stage study met the primary efficacy endpoint of non-inferiority and continued to show its ability to maintain hemoglobin (Hb) levels over time.
Commenting on the extended Roxadustat approval, Peony Yu – Chief Medical Officer of FibroGen said: “By bringing roxadustat to adult patients living with anemia of CKD, both on dialysis and not on dialysis, we are continuing our efforts to meet the significant unmet medical need of patients in this community.”
Roxadustat is an orally administered inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase (PH). It has been designed to boost the levels of hemoglobin through a different mechanism of action compared to traditional erythropoiesis-stimulating agents (ESAs).
As a HIF-PH inhibitor, roxadustat is said to trigger the natural protective response of the body to reduced oxygen levels in the blood. This response involves the controlling of multiple, coordinated processes that help in the correction of anemia.
For adult patients, the usual dosage is 50 mg, the starting dose with roxadustat to be administered orally three times a week. Roxadustat dosing thereafter should be adjusted as per the condition of the patient.
However, the maximum dose of the drug should not be more than 3.0 mg/kg.
For patients changing from erythropoiesis-stimulating agents, roxadustat dosing for adults should be 70 or 100 mg as the starting dose administered orally three times weekly. The dosage thereafter should be adjusted as per the condition of the patient and the maximum dose should not be more than 3.0 mg/kg.