TOKYO, November 20, 2019  - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ) today announced launch of Evrenzo® Tablet 20mg, 50mg and 100mg (generic name: roxadustat) in Japan, an oral HIF-PH (hypoxia-inducible factor prolyl hydroxylase) inhibitor, for the treatment of renal anemia in patients on dialysis.

Evrenzo® is a first-in-class orally administered HIF-PH inhibitor that corrects anemia by a mechanism of action that is different from that of erythropoiesis-stimulating agents (ESAs). Evrenzo® activates a response that occurs naturally when the body responds to reduced oxygen levels in the blood. The response activated by Evrenzo® involves the regulation of multiple, complementary processes to promote erythropoiesis and increase the blood’s oxygen-carrying capacity.

Astellas has been developing roxadustat in collaboration with FibroGen, Inc. (Nasdaq: FGEN) under the license agreement. In Japan, the clinical development for roxadustat is being conducted by Astellas, and roxadustat is currently in Phase 3 for renal anemia in patients not on dialysis in addition to the approved indication of renal anemia in patients on dialysis.

Anemia is a frequent complication of chronic kidney disease (CKD), occurring in over 90% of patients on dialysis.1 The number of patients on dialysis in Japan is increasing year by year and exceeded 330,000 in 2017.2 CKD anemia can severely worsen the outcomes of kidney disease, increasing the rate of progression to renal failure3 and the likelihood of cardiovascular complications.4 It also significantly reduces patients’ quality of life and their cognitive ability.5

By offering Evrenzo® in Japan as a new treatment option, Astellas will continue to contributing to treatment of renal anemia where unmet needs still remain.

 

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