The US Food and Drug Administration (FDA) has declined to approve AstraZeneca and FibroGen’s new drug application (NDA) for roxadustat to treat anaemia associated with chronic kidney disease (CKD).
The application is for the use of roxadustat in adult non-dialysis dependent (NDD) and dialysis-dependent (DD) patients.
FDA issued a complete response letter (CRL) to AstraZeneca and FibroGen, requesting an additional clinical study to check the safety of roxadustat in NDD and DD patients before the resubmission of NDA.
Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that promotes erythropoiesis, or red blood cell production.
AstraZeneca stated that the safety and efficacy of roxadustat have already been tested in the Phase III programme, which was performed in more than 8,000 patients.
Carried out by AstraZeneca, FibroGen and Astellas Pharma, this programme comprised the OLYMPUS, ALPS and ANDES trials that compared roxadustat to placebo in NDD-CKD patients.
The programme also involved the ROCKIES, SIERRAS and HIMALAYAS trials, which assessed roxadustat versus epoetin alfa in DD-CKD and incident dialysis patients.
The drug is approved in several countries, including China, Chile, South Korea and Japan under the name Evrenzo, to treat anaemia associated with CKD in both NDD and DD adult patients.
In Europe, Astellas submitted the marketing authorisation application for Evrenzo to treat this patient population. The European Medicines Agency (EMA) accepted the application for review in May last year.
In June this year, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of roxadustat, which is currently under final regulatory review.
Astellas and AstraZeneca also submitted many other licensing applications for the drug to regulatory authorities globally.
Furthermore, the drug is in clinical development for the treatment of anaemia related to myelodysplastic syndromes (MDS) and for chemotherapy-induced anaemia (CIA).