AstraZeneca PLC and FibroGen Inc.'s roxadustat showed effectiveness in treating anemia in patients with chronic kidney disease, or CKD, under late-stage trials called Olympus and Rockies.
The 2,781-subject Olympus study was evaluating the therapy in non-dialysis dependent patients whose disease progression was moderate to severe; while the 2,133-patient Rockies study was evaluating roxadustat in patients who are dialysis dependent.
Anemia causes a lack of red blood cells or hemoglobin in patients. The trials were evaluating roxadustat's efficacy by measuring hemoglobin change from baseline at weeks 28 and 52.
Under both phase 3 studies, patients taking roxadustat showed a statistically significant and clinically meaningful improvement in hemoglobin levels compared to those given placebo.
Results from Olympus and Rockies mirror the results of another late-stage study of roxadustat, called Alps, where the therapy was shown to work better than placebo in treating anemia in patients with CKD who are not on dialysis.
U.K.-based AstraZeneca and San Francisco-based FibroGen are collaborating to commercialize roxadustat in China, the U.S. and other markets. FibroGen is also teaming up with Tokyo's Astellas Pharma Inc. to commercialize the medicine in Japan, Europe, the Commonwealth of Independent States, the Middle East and South Africa.