EMA Accepts Astellas' Marketing Authorization Application For Roxadustat

(RTTNews) - Astellas Pharma Inc. and FibroGen Inc. (FGEN) said that the European Medicines Agency has accepted the marketing authorization application for roxadustat for regulatory review. roxadustat is a drug for treatment of anemia in adult patients with chronic kidney disease.

EMA's acceptance of the roxadustat MAA for treatment of anemia in adult patients with chronic kidney disease on dialysis and not on dialysis triggers a milestone payment of $130 million by Astellas to FibroGen.

Chronic kidney disease is a progressive loss of kidney function caused by damage to the kidneys resulting from conditions such as hypertension, diabetes or immune-regulated inflammatory conditions.

Anemia is a common complication of CKD,resulting from the failing kidneys' diminished ability to produce erythropoietin, which stimulates red blood cell production in the bone marrow. It is associated with significant morbidity and mortality in dialysis and non-dialysis populations, increasing in both prevalence and severity as kidney disease worsens.

Anemia associated with CKD increases the risk of adverse cardiovascular events, worsens renal outcomes and can negatively impact patients' quality of life.

Roxadustat is approved and launched for the treatment of anemia associated with CKD in Japan in DD patients and in China in both DD and NDD patients. A supplemental New Drug Application has been submitted to Japan's Pharmaceuticals and Medical Devices Agency for NDD patients and a New Drug Application has been submitted in the US in both DD and NDD patients.