FibroGen receives Complete Response Letter from the FDA for roxadustat for anemia of chronic kidney disease – FibroGen + AstraZeneca

The FDA has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for roxadustat for the treatment of anaemia 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.

AstraZeneca is working with its partner FibroGen, Inc. (FibroGen) and the FDA to evaluate next steps. The safety and efficacy of roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, have been demonstrated in the Phase III programme including more than 8,000 patients and published in five peer-reviewed journal articles.