FibroGen and AstraZeneca new drug application (NDA) for roxadustat to treat anaemia associated with chronic kidney disease (CKD) has been rejected by the US Food and Drug Administration (FDA).
The application highlights the usage of roxadustat in adult patients who are non-dialysis dependent (NDD) and dialysis-dependent (DD).
Before resubmitting NDA, FDA delivered a complete response letter (CRL) to AstraZeneca and FibroGen, demanding a further medical study to check the safety of roxadustat in NDD and DD patients.
Roxadustat being an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) trammel agent, encourages red blood cell production or erythropoiesis.
AstraZeneca specified that in the Phase III programme which was done in more than 8,000 patients, they have already tested the safety and efficacy of roxadustat.
This programme, which was carried out by FibroGen, Astellas Pharma and AstraZeneca, included the trials of ANDES, OLYMPUS and ALPS that assessed NDD-CKD patients’ placebo to roxadustat.
The HIMALAYAS, SIERRAS and ROCKIES trials were also comprised of this programme, which compared epoetin alfa in DD-CKD and incident dialysis patients against roxadustat.
Using the name Evrenzo, the drug is permitted in numerous countries including Japan, Chile, South Korea and China to treat anaemia related with CKD in both DD and NDD adult patients.
Astellas submitted the advertising approval application in Europe for Evrenzo to treat the patients. In May last year, The European Medicines Agency (EMA) approved the application for evaluation.
EMA’s Committee for Medicinal Products for Human Use (CHMP) suggested the acceptance of roxadustat in June this year, which is under final regulatory evaluation currently.
Many other licensing applications are also submitted by AstraZeneca and Astellas for the drug to regulatory authorities internationally.
Moreover, the drug is in clinical development for the treatment of anaemia associated to chemotherapy-induced anaemia (CIA) and for myelodysplastic syndromes (MDS).
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