FDA rejects roxadustat for anemia of chronic kidney disease
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The FDA issued a complete response letter to FibroGen indicating it cannot approve the company’s new drug application that seeks approval of roxadustat for anemia of chronic kidney disease.
The agency requested additional clinical study of roxadustat be conducted before the application is resubmitted.
Roxadustat (FibroGen/AstraZeneca) acts as a hypoxia-inducible factor prolyl-hydroxylase inhibitor that promotes red blood cell production through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.
“We are deeply disappointed with this result, and this is an unfortunate day for patients suffering from anemia of chronic kidney disease in the United States,” Enrique Conterno, FibroGen’s CEO, said in a company-issued press release. “Roxadustat is changing the lives of patients around the world, and we and our partner AstraZeneca will discuss next steps in the U.S.”
Roxadustat is approved in Chile, Japan, China and South Korea for treatment of anemia of chronic kidney disease for both dialysis-dependent and nondialysis-dependent adults. The European Commission is expected to make a decision on the agent by the end of August.
The FDA issued its complete response letter about 4 weeks after the agency’s Cardiovascular and Renal Drugs Advisory Committee voted against approval of roxadustat for the treatment of anemia due to chronic kidney disease.
Citing safety concerns, committee members voted 13-1 against roxadustat for patients with nondialysis dependent chronic kidney disease. The panel voted 12-2 against approval of the drug for patients on dialysis.
Roxadustat also is in development for anemia associated with myelodysplastic syndrome, as well as for chemotherapy-induced anemia.
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