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Roxadustat Approval Might Hinge On Additional Safety Analyses After FibroGen Admits Manipulating Data

 
• By Cathy Kelly

With superiority over epoetin apparently off the table, FibroGen and AstraZeneca expect a US FDA advisory committee in July, and hope that additional safety analyses for roxadustat will help support a positive overall risk-benefit profile.

Superior Safety Data Discredited Ahead Of FDA Panel Meeting • Source: Shutterstock

FibroGen, Inc. will present additional safety analyses for its roxadustat at the upcoming US Food and Drug Administration advisory panel review of the drug that will help support a positive overall risk-benefit profile, company executives said on 7 April.

The additional analysis could bolster prospects for FibroGen’s first-in-class candidate for treating anemia in chronic kidney disease now that it appears the evidence around the relative safety of roxadustat in...

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