FibroGen admits false safety data presented for roxadustat

USA-based FibroGen’s (Nasdaq: FGEN) shares plunged almost 30% to $24.09 in pre-market trading today, on a disclosure of false heart safety data from previous presenations for its regulatory filing with the Food and Drug Administration on its anemia treatment in chronic kidney disease (CKD) patients.

FibroGen, which is partnered with AstraZeneca (LSE: AZN) and Astellas (TYO: 4503), issued a clarification of certain prior disclosures of US primary cardiovascular safety analyses from the roxadustat Phase III program for the treatment of anemia of CKD.

“As members of senior management were preparing for the upcoming FDA Advisory Committee meeting, we became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors,” said Enrique Conterno, chief executive of FibroGen, adding: “While all of the analyses set forth below, including the differences in the stratification factors, were included in the NDA, we promptly decided to clarify this issue with the FDA and communicate with the scientific and investment communities.”