Roxadustat Stacks Up To Darbepoietin In Non-Dialysis Anemia
Plus Positive CV Signals
Astellas’s oral HIF-PH inhibitor shows non-inferiority to one established ESA in head-to-head trial and while there were cardiovascular benefits, the picture is complex.
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Touted in China after its first approval globally there for chronic kidney disease-associated anemia back in late 2018, FibroGen/AstraZeneca's roxadustat has now been rejected by the US FDA over cardiovascular safety concerns. But ex-US markets may still enable the drug to shine despite safety wording.
The FDA has almost 30 decision dates coming up before New Year’s Eve, including nearly a dozen novel agents.
HIF-PHI inhibitor failed to show non-inferiority to ESAs in the primary cardiovascular safety endpoint of a Phase III program for the treatment of anemia due to chronic kidney disease.