FibroGen plunges 43% after the company says there were errors in safety analyses data for its anemia drug candidate
FibroGentumbled 43% after issuing a clarification on late-stage safety analyses for its anemiadrug candidate, roxadustat.
- The company said it identified "post-hoc changes to the stratification factors."
- FibroGen has a meeting in July with an
FDAcommittee about its new drug applicationfor roxadustat.
FibroGen shares plunged as much as 43% on Wednesday after the biopharmaceutical developer said there were errors in certain disclosures about safety analyses for its anemia drug candidate roxadustat.
In a late Tuesday statement about phase 3 testing data for roxadustat, FibroGen CEO Enrique Conterno said the company "became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors."Conterno said the company became aware of the changes to the stratification factors as members of senior management prepared for a meeting with the Food and Drug Administration's advisory committee about roxadustat.
FibroGen said it now cannot conclude that roxadustat is superior to reducing risks of cardiovascular events compared with epoetin-alfa, an already approved drug that can aid the body in producing red blood cells. Roxadustat is aimed at orally treating anemia in chronic kidney disease patients who are dependent or non-dependent on dialysis."It is important to emphasize that this does not impact our conclusion regarding the comparability, with respect to cardiovascular safety, of roxadustat to epoetin-alfa in dialysis-dependent patients and to placebo in non-dialysis dependent patients," said Conterno. "We continue to have confidence in roxadustat's benefit risk profile."
The FDA's advisory committee is tentatively scheduled to review the roxadustat application on July 15.
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