Blow for FibroGen as US FDA panel votes against roxadustat
USA-based FibroGen's (Nasdaq: FGEN) shares have dropped by more than a third after a scientific panel of the US Food and Drug Administration voted against approval of roxadustat.
The committee voted 13 to one against roxadustat as a treatment for anemia in chronic kidney disease (CKD) in non-dialysis dependent adults, and 12 to two against approval as a treatment for anemia in CKD in dialysis-dependent adults.
In the meeting, panellists discussed the safety profile of the medicine, and concluded that more safety data should be generated before approval is granted.
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