FibroGen Presents Late-Breaker Abstract Results on Associations between Hemoglobin Levels and Cardiovascular Outcomes in Roxadustat-Treated Patients with Anemia of Chronic Kidney Disease (CKD)
FibroGen announced the results from two analyses of pooled data from the roxadustat global Phase 3 development program, which were presented at the ASN Kidney Week 2020. The analyses revealed that Major Adverse Cardiovascular Events (MACE) rates in chronic kidney disease (CKD) patients were highest when hemoglobin (Hb) was below 8 g/dL. Rates decreased as Hb increased and were lowest when Hb levels reached or exceeded 10 g/dL. This data supports roxadustat's efficacy and potential as a treatment for anemia in CKD patients.
- Roxadustat shows effectiveness in boosting hemoglobin levels in CKD patients.
- Lower rates of cardiovascular events (MACE) in patients with hemoglobin ≥ 10 g/dL.
- None.
In non-dialysis and dialysis-dependent CKD patients, Major Adverse Cardiovascular Event (MACE) and MACE+ incidence rates were lowest when patients achieved hemoglobin levels ≥ 10 g/dL
Two analyses of pooled data from the roxadustat global Phase 3 development program to be presented during the American Society of Nephrology Kidney Week 2020 Reimagined
SAN FRANCISCO, Oct. 22, 2020 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced results from two analyses of pooled data from the roxadustat global Phase 3 development program, examining associations between the achieved hemoglobin (Hb) levels and cardiovascular outcomes of both non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients with anemia of chronic kidney disease (CKD). Results of the analyses of three trials in NDD patients and three trials in DD patients, respectively, showed that Major Adverse Cardiovascular Events (MACE; all-cause mortality, myocardial infarction, and stroke) and MACE+ (MACE plus heart failure or unstable angina requiring hospitalization) rates were highest when Hb was less than 8 g/dL, decreased as Hb increased, and were lowest when Hb levels were greater than or equal to 10 g/dL.
These data (Abstracts PO2625 and PO2626) were accepted as late-breaking abstracts and will be featured in the Late-Breaking Clinical Trials Posters session at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined on October 22 at 10 AM.
“We have evidence that roxadustat is effective in increasing and maintaining hemoglobin levels in patients with anemia of chronic kidney disease, as shown across the roxadustat clinical program. These new post-hoc analyses showed that for patients who were treated with roxadustat, rates of cardiovascular events were lowest in patients when their hemoglobin levels were greater than 10 g/dL,” said Robert Provenzano, MD, Associate Professor of Medicine, Wayne State University, Detroit, Michigan, U.S. and a primary investigator in the roxadustat global Phase 3 program. “These additional safety results, coupled with roxadustat’s well-defined efficacy profile and its oral formulation, support the potential for roxadustat to become a safe and effective treatment option for anemia of chronic kidney disease, an area that has seen little therapeutic progress in the last 30 years.”
In both analyses, incidence rates of adjudicated MACE and MACE+ were evaluated based on Hb level immediately before the event. In the NDD CKD population, MACE and MACE+ rates were highest when Hb was less than 8 g/dL, decreased as Hb increased and were lowest when achieved Hb levels were greater than or equal to 10 g/dL.
| Parameter | Maximum Hemoglobin | |||||||
| < 8 g/dL | 8 - < 9 g/dL | 9 - < 10 g/dL | 10 - < 11 g/dL | 11 - < 12 g/dL | ≥ 12 g/dL | |||
| Outcome | Time point | Event rate/100 PEY ( | ||||||
| MACE | Immediately before event |
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FAQ
What are the findings from the FibroGen roxadustat study presented at ASN Kidney Week 2020?
The study indicated that hemoglobin levels greater than or equal to 10 g/dL resulted in the lowest rates of Major Adverse Cardiovascular Events (MACE) among CKD patients.
What is the significance of hemoglobin levels in CKD patients according to FibroGen's research?
FibroGen's research highlighted that higher hemoglobin levels correlate with reduced cardiovascular event rates in CKD patients, specifically below 8 g/dL showing the highest MACE incidence.
When was the roxadustat data presented?
The roxadustat data was presented at the American Society of Nephrology Kidney Week 2020 on October 22.
What is the primary focus of the roxadustat clinical program by FibroGen?
The primary focus is to demonstrate the efficacy of roxadustat in treating anemia associated with chronic kidney disease.
FibroGen, Inc
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