FibroGen’s anemia drug fails to meet main goal in late-stage trial
May 5 (Reuters) – FibroGen Inc (FGEN.O) said on Friday its anemia drug had failed to meet the main goal in a late-stage trial, sending its shares tumbling nearly 12% before the bell.
The miss is the latest setback for the company whose application seeking approval for the drug to treat anemia in kidney disease patients was rejected by the U.S. Food and Drug Administration in 2021 seeking additional data.
The drug was being studied for the treatment of anemia in patients with a type of bone marrow cancer who are dependent on transfusion.
The primary goal of the study had been transfusion independence for more than 56 consecutive days during the first 28 weeks of the treatment, and patients were followed for up to 52 weeks.
FibroGen said 47.5% of patients who were on its drug, roxadustat, achieved red blood cell transfusion independence in the first 28 weeks, compared with 33.3% for the placebo, but the difference was not statistically significant.
The safety of the drug will be further evaluated at study completion, the company said.
The study was sponsored and conducted by FibroGen and is part of its co-development collaborations with AstraZeneca (AZN.L) and Astellas Pharma Inc (4503.T).
Roxadustat, an oral drug, belongs to a class of medicines comprising HIF-PH inhibitors that promote red blood cell production.
The company is also evaluating the drug as a treatment of chemotherapy-induced anemia in a late-stage study.
Roxadustat has been approved in China, Europe, Japan, and numerous other countries for the treatment of anemia associated with chronic kidney disease in adult patients on dialysis and not on dialysis.
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