- FibroGen Inc (NASDAQ: FGEN) stock plummeted after hours on Tuesday after a murky disclosure for roxadustat, the company’s anemia treatment in chronic kidney disease patients.
- While preparing for an advisory committee meeting ahead of potential approval of roxadustat, FibroGen said it realized it submitted altered information to the FDA about the drug’s cardiovascular safety.
- The FDA has tentatively scheduled a Cardiovascular and Renal Drug Advisory Committee on July 15.
- According to CEO Enrique Conterno, FibroGen senior management became “aware” that post hoc changes had been made to stratification factors used to assess their drug’s hazard ratio to enhance how much the therapy reduced key risks for patients.
- Using pre-specified stratification factors raised the risk on critical safety endpoints, which revolved primarily around MACE, a composite endpoint of all-cause mortality, stroke, and myocardial infarction.
- Now, FibroGen says the new data suggest roxadustat might not be superior to another drug called epoetin-alfa in lowering the risk of cardiovascular events in some patients.
- “There is no change in the underlying roxadustat data or to the (effectiveness) analyses from the Phase 3 program,” FibroGen said. The company has begun a comprehensive internal review to ensure such issues do not occur in the future.”
- FibroGen is collaborating on developing and commercializing roxadustat with AstraZeneca Plc (NASDAQ: AZN) and Astellas Pharma (OTCMKT: ALPMY) in specific locations.
- Price Action: FGEN shares are down 25.2% at $25.91 in the premarket trading on the last check Wednesday.
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