FDA Extends PDUFA Date for Roxadustat

The US Food and Drug Administration (FDA) has extended the action date for roxadustat, a potential treatment for anemia of chronic kidney disease (CKD).

The agency announced the new Prescription Drug User Fee Act (PDUFA) action date of March 20, 2021 for the New Drug Application from FibroGen.

The FDA is also close to finalizing the review of the NDA, with FibroGen submitting additional analyses of existing roxadustat clinical data, which require an extension of the original December 20, 2020 PDUFA date.

“FibroGen is working closely with the FDA, in collaboration with our partner, AstraZeneca, to support the final review of the new drug application for roxadustat,” said Enrique Conterno, Chief Executive Officer, FibroGen, in a statement. “There is significant unmet medical need for the treatment of anemia of CKD, and we are committed to bringing roxadustat to patients in the U.S. as soon as possible.”

Roxadustat is an oral, small molecule, hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. The treatment represents the first HIF-PH inhibitor accepted by the FDA for review to treat anemia of CKD.

The application is based on positive results from a global phase 3 program involving more than 8000 patients.

Anemia is a common early complication of chronic kidney disease, affecting approximately 20% of CKD patients. Roxadustat works by increasing endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin.

The treatment is currently approved in China, Japan, and Chile for the treatment of anemia of chronic kidney disease in adult patients on dialysis and not on dialysis.