Update on US Regulatory Review of Roxadustat in Anaemia of Chronic Kidney Disease

The US 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.

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 program including more than 8,000 patients and published in five peer-reviewed journal articles.

Roxadustat is approved in a number of countries, including China and Japan, for the treatment of anemia in CKD in NDD and DD adult patients. It is under regulatory review in other jurisdictions, including in the European Union, where it has recently received a positive CHMP opinion.