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