FibroGen’s new PhIII data set it up for quick OK, analysts say. But can it avoid a black box warning?
Less than two months out from its PDUFA date, FibroGen has rolled out a slate of Phase III data on roxadustat that analysts say all but seals the deal on a broad OK for anemia associated with CKD. A black box warning, though, may still dim its prospects.
FibroGen presented data from six different Phase III studies at the American Society of Nephrology Kidney Week, covering a broad spectrum of CKD patients both dialysis-dependent and non-dialysis-dependent. Notably, the AstraZeneca-partnered drug scored some positive numbers on MACE and MACE+ rates in a pooled safety analysis, suggesting non-inferiority to placebo on cardio outcome.
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