FDA Rejects FibroGen’s Roxadustat for Treating CKD-Linked Anemia
The FDA has issued a Complete Response Letter to San Francisco biotech FibroGen for roxadustat, its investigational drug for anemia linked to chronic kidney disease (CKD), calling for an additional clinical study before the agency will consider approving the drug.
“We are deeply disappointed with this result, and this is an unfortunate day for patients suffering from anemia of CKD in the United States,” FibroGen CEO Enrique Conterno said. “Roxadustat is changing the lives of patients around the world, and we and our partner AstraZeneca will discuss next steps in the U.S.”
The news comes less than four weeks after the FDA’s Cardiovascular and Renal Drugs Advisory Committee said the drug should not be approved, citing concerns about the drug’s safety.