Akebia's Vadadustat Misses In Non-Dialysis CKD, But Filings Still Planned For 2021
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.
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Akebia Could Face Long, Costly Effort To Overcome Vadadustat CRL
The US FDA turned down approval for vadadustat in chronic kidney disease anemia, in a complete response letter that unexpectedly included the dialysis-dependent indication.
Restructuring On The Table For FibroGen After Roxadustat Rejection
As anticipated, the FDA issued a complete response letter for roxadustat. While the drug is expected to win EU approval, it is unclear if FibroGen and AstraZeneca will be willing to fund another trial.
Roxadustat CKD Doubts Fanned By FibroGen Data Blunder
AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.