Akebia shares MACEd as their PhIII anemia drug fails on safety, offering rival FibroGen a huge advantage
Akebia $AKBA slammed directly into an unexpected brick wall Thursday morning, as the biotech reported a critical failure in its second Phase III study of its anemia drug vadadustat.
The drug hit the primary and key secondaries for efficacy in a late-stage study pitting the drug against the injectable ESA darbepoetin alfa among chronic kidney disease patients not on dialysis. But it failed on the all-important MACE non-inferiority standard for safety, tracking time to first occurrence of major adverse cardiovascular events.
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