Tokyo-based Astellas Pharma Inc. and FibroGen Inc. said their medicine roxadustat cleared another late-stage trial in Japan.
The companies were evaluating whether their drug worked as well as darbepoetin alfa, the current standard of care, in treating anemia, a deficiency of red blood cells in patients with dialysis-dependent chronic kidney disease, or CKD.
This was the fourth of six studies that the companies were undertaking in Japan. "The positive topline results from this latest Japan phase 3 study are consistent with previously reported results from roxadustat phase 3 studies in Japan and in China, and from our extensive phase 2 program," San Francisco-based FibroGen's Chief Medical Officer, K. Peony Yu, said in a statement.
Roxadustat was well-tolerated and the safety profile was consistent with that observed in previous studies both in dialysis and non-dialysis patients.
The two companies are working to commercialize the medicine in Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa.
FibroGen is also collaborating with AstraZeneca PLC to commercialize the medicine in China, the U.S. and other markets.
