A Phase 3 clinical trial, HIMALAYAS, evaluating FibroGen’s (FGEN -6%) roxadustat in chronic kidney disease (CKD) patients who recently initiated dialysis met both primary endpoints. The data were presented at the American Society of Nephrology Kidney Week in Washington, DC.
The open-label study randomized participants 1:1 to receive either roxadustat or epoetin alfa (originally marketed by Amgen under the brand name Epogen) for up to 4.4 years (mean duration of treatment was 1.8 years).
Results showed that treatment with roxadustat increased mean hemoglobin levels from 8.4 g/dL to 11.0 g/dL compared to an increase from 8.4 g/dL to 10.8 g/dL for epoetin alfa demonstrating its non-inferiority (no worse than).
Roxadustat was also non-inferior to epoetin alfa in terms of the proportion of patients achieving a hemoglobin response during the first 24 weeks of treatment (88.2% vs. 84.4%).
Patients receiving roxadustat also required less monthly intravenous iron on average.
On the safety front, the most frequent roxadustat-related adverse events were hypertension, diarrhea and muscle spasms.
Collaboration partner AstraZeneca (AZN -0.2%) will be presenting data from two Phase 3s, OLYMPUS and ROCKIES, assessing roxadustat for the treatment of anemia in non-dialysis and dialysis-dependent CKD patients at the meeting.
The stock remains under pressure from a bearish report from Plainview published on Monday. Share have lost 11% of their value since then.
Related ticker: Astellas Pharma (OTCPK:ALPMY -1.2%)
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