UPDATED: FDA raises safety, efficacy questions for FibroGen's anemia drug roxadustat with adcomm on the horizon
Ahead of Thursday’s meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, the agency is raising fresh doubts on whether FibroGen’s anemia drug roxadustat will cross the finish line.
New safety questions for roxadustat, a first-in-class inhibitor of HIF-PH enzymes, are emerging in the FDA’s briefing documents as the drug has been criticized for manipulating cardiovascular safety data after it had to double back and inform the FDA of some post-hoc statistical changes that some Wall Street analysts like Michael Yee at Jefferies said were material.
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