FibroGen will look to expand the label of roxadustat in China after announcing positive topline results for a Phase III trial in chemotherapy induced anaemia.

The Phase III roxadustat study (NCT05301517) met its primary endpoint of noninferiority versus 3SBio’s SEPO (erythropoietin alfa) along the primary endpoint of change in haemoglobin level. FibroGen’s open-label trial enrolled 159 patients receiving concurrent chemotherapy treatment for non-myeloid malignancies.

Though roxadustat has found success in Asia and Europe, the small molecule has not yet garnered regulatory support in the US.

Roxadustat is currently marketed for the treatment of anaemia in chronic kidney disease as Ai Ruizhuo in China, and as Evrenzo in the EU, the UK, Japan, and Russia, among other countries. However, the US Food and Drug Administration (FDA) rejected the roxadustat application for the same indication.

An FDA Advisory Committee had raised concerns over the safety of roxadustat for anaemia in chronic kidney disease, though subsequent safety data has appeared to support the drug’s use in countries where it is approved.

FibroGen and AstraZeneca collaboration

FibroGen has announced that it plans to file a New Drug Application in China for roxadustat in chemotherapy induced anaemia as part of an ongoing collaboration with AstraZeneca.

Astellas Pharma and FibroGen are developing and commercialising roxadustat in the EU, the UK, Japan, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen has collaborated with AstraZeneca to develop and commercialise the drug in the US, China and other markets that are not licensed to Astellas.