FibroGen Inc. filed an application seeking U.S. approval of its anemia drug Evrenzo, or roxadustat, for patients with chronic kidney disease.
Evrenzo is already approved in Japan for dialysis-dependent patients and in China for both non-dialysis-dependent and dialysis-dependent patients.
The San Francisco-based biotechnology company's new drug application with the U.S. Food and Drug Administration is based on results from 15 phase 3 trials — including Olympus, Andes, Alps, Himalayas, Sierras and Rockies — that evaluated Evrenzo's efficacy and safety in about 10,000 patients globally.
Low levels of hemoglobin, an oxygen-carrying protein in red blood cells, and insufficient red blood cells can lead to anemia, a potentially life-threatening condition common in patients with chronic kidney disease.
FibroGen is collaborating with Britain's AstraZeneca PLC to commercialize roxadustat for the treatment of anemia in the U.S. and certain other geographies.