FDA has accepted a new drug application (NDA) for the oral hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor vadadustat from Akebia Therapeutics (NSDQ:AKBA) and its partner Otsuka Pharmaceutical Co. (TYO:4578).
The two companies are pursuing the use of the drug to treat anemia resulting from chronic kidney disease.
The oral drug would offer patients more flexibility than anemia treatments known as Erythropoiesis-stimulating agents, which are injectable drugs that stimulate the bone marrow to produce red blood cells.
FDA has assigned the application a standard review and has set a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022.
The agency is not intending on holding an Advisory Committee meeting for the application.
In a statement, Akebia CEO John P. Butler said the company looks “forward to working with the FDA” as it reviews the application. “In addition, we continue to collaborate with our partners to ensure we are well positioned to support a successful commercial launch of vadadustat, upon FDA approval,” Butler added.
The FDA’s NDA acceptance “highlights [Akebia’s and Otsuka’s] ongoing execution as well as our shared commitment to advancing vadadustat with the goal of bringing this novel therapeutic to patients as soon as possible, subject to regulatory approval,” said Kabir Nath, board member of Otsuka Pharmaceutical Co.
By the end of the year, the two companies also intend to file the Marketing Authorization Application for vadadustat with the European Medicines Agency.
In April, NEJM published a study concluding that vadudustat was noninferior to darbepoetin alfa in terms of cardiovascular safety and its ability to maintain hemoglobin concentrations in patients undergoing dialysis.
Fibrogen is pursuing FDA approval for roxadustat, which is a similar drug to vadadustat.
Filed Under: Drug Discovery and Development, Hematology, Nephrology/urology