The US Food and Drug Administration has concerns about “obvious” and “prominent” signals for serious thrombotic events, seizures and infection with FibroGen, Inc.’s anemia drug roxadustat.
FibroGen’s Roxadustat Faces US FDA Scrutiny On ‘Prominent’ Safety Signals Relative To Erythropoietin
Risks of serious thrombotic events, seizures and infection make the benefits of the first-in-class oral drug for treating anemia related to chronic kidney disease ‘difficult to calculate’ despite demonstrated improvements in hemoglobin, FDA says in advisory committee briefing document.
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