Tokyo-based Astellas Pharma Inc. and FibroGen Inc.'s roxadustat, or Evrenzo, has been approved in Japan to treat anemia associated with chronic kidney disease in dialysis patients.
Japan's Ministry of Health, Labour and Welfare approved the drug on the basis of four phase 3 studies conducted in the country, which showed that Evrenzo was effective in raising hemoglobin levels.
Anemia affects about 20% of chronic kidney disease patients and is on the rise in Japan. It results from the failing kidneys' diminished ability to produce the hormone erythropoietin, which stimulates red blood cell production from the bone marrow, affecting both dialysis and non-dialysis patients, the company said in a Sept. 20 press release. Anemia can worsen the outcome for kidney disease patients and increase the likelihood of cardiovascular complications, Astellas said.
Roxadustat is already approved in China to treat dialysis-dependent and non-dialysis-dependent chronic kidney disease patients. The therapy is in phase 3 clinical development in the U.S. and Europe and in phase 2/3 development in China for anemia associated with myelodysplastic syndromes.
This is the first approval in Japan received by Astellas and FibroGen, who are collaborating to develop roxadustat for the treatment of anemia in Japan, Europe, the Middle East and South Africa. FibroGen is also partnered with AstraZeneca PLC for development and commercialization of the drug in the U.S., China and other markets.
