FDA declines to approve FibroGen's roxadustat for anaemia of CKD

Roxadustat is an oral drug approved in various countries for anaemia treatment in adult NDD and DD-CKD patients. Credit: Steve Buissinne / Pixabay. The US Food and Drug Administration (FDA) has declined to approve the new drug application (NDA) for FibroGen's roxadustat to treat anaemia in chronic kidney disease (CKD) patients. Being developed in alliance with AstraZeneca and Astellas Pharma, roxadustat is an oral inhibitor of hypoxia-inducible factor prolyl hydroxylase (HIF-PH). The drug is intended for use in non-dialysis dependent (NDD) as well as dialysis-dependent (DD) adult patients with CKD. FibroGen received a complete response letter (CRL) from the FDA,…