UPDATED: Safety concerns push FDA adcomm to vote overwhelmingly against approval for FibroGen anemia drug
The FDA’s Cardiovascular and Renal Drugs Advisory Committee on Thursday afternoon voted 12 to 2 against approving AstraZeneca and FibroGen’s anemia drug roxadustat as a treatment of anemia due to chronic kidney disease in adult patients on dialysis, and the committee voted 13-1 against approval for patients not on dialysis.
Overall, adcomm members raised questions related to the cardiovascular safety of the drug and a lack of a signal related to quality-of-life improvements, under-representation of African Americans in the global trials, as well as concerns with the company’s planned post-marketing study and dosing changes.
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