The Food and Drug Administration has set a new Prescription Drug User Fee Act (PDUFA) date for the New Drug Application for roxadustat. The Agency announced that additional clarification of clinical data was needed prior to completing the review. The new action date is now March 20, 2021.
Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is under review for the treatment of anemia of chronic kidney disease (CKD) in both nondialysis-dependent and dialysis-dependent patients. The investigational agent promotes erythropoiesis by increasing endogenous erythropoietin production.
The NDA submission is supported by data from a global phase 3 program that included over 8000 patients. To aid in the completion of labeling discussions, AstraZeneca and FibroGen have agreed to submit additional clarifying analyses to the FDA.
For more information visit astrazeneca.com.
Update on US regulatory review of roxadustat in anaemia of chronic kidney disease. [press release]. December 18, 2020.