AZ/FibroGen's Roxadustat Superior To Epoetin-Alfa In Chronic Renal Disease With Anemia

Positive top-line Phase III data from five studies, including the finding of superior efficacy to epotin-alfa, puts roxadustat in the driving seat as a new class of anemia agents heads toward the marketplace, but cardiovascular safety needs confirming.  

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Top-line data on roxadustat has flowed from AstraZeneca and FibroGen • Source: Shutterstock

Just days after AstraZeneca PLC and FibroGen Inc. announced the first approval of the first-in-class anemia therapy, roxadustat, AstraZeneca has released top-line data from two Phase III clinical studies, OLYMPUS and ROCKIES, and FibroGen has released top-line data from three Phase III studies, ANDES, HIMALAYAS and SIERRAS, all showing that their primary endpoints were met.

With the first approval of roxadustat in hand, in China, the outcome of the Phase III trials was not entirely...

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