FDA issues CRL on roxadustat in anemia of chronic kidney disease
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.
The CRL requested an additional clinical trial on the safety of roxadustat in both the NDD and DD patient populations, according to UK pharma major AstraZeneca (LSE), which is partnering on the drug with USA-based FibroGen (Nasdaq: FGEN), whose shares were down 3.3% at $12.75 by mid-morning.
The decision comes after an FDA advisory committee last month voted 13 to one against approval of roxadustat as a treatment for anemia in chronic kidney disease (CKD) in non-dialysis dependent adults, citing safety concerns, and 12 to two against approval as a treatment for anemia in CKD in dialysis-dependent adults.
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