FDA accepts filing of new drug application for vadadustat
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Akebia Therapeutics Inc. recently announced the FDA accepted its filing of a new drug application for vadadustat for the treatment of anemia in patients with chronic kidney disease.
The FDA assigned a Prescription Drug User Fee Act target action date for the oral hypoxia-inducible factor prolyl hydroxylase inhibitor of March 29, 2022, according to a press release from Akebia.
“The acceptance of our vadadustat [new drug application] NDA filing marks another important milestone for Akebia and Otsuka [Pharmaceutical Co., Ltd.], as we work to bring a new oral treatment option to patients living with anemia due to CKD,” John P. Butler, CEO of Akebia, said in the release. “We remain confident in the clarity and quality of our data, and we look forward to working with the FDA during their review of our application.”
The NDA is for both patients with end-stage kidney disease on dialysis and for patients with CKD not on dialysis. Last September, Akebia said vadadustat reached primary and key secondary efficacy endpoints in phase 3 PRO2TECT cardiovascular outcomes studies for patients with CKD not on dialysis, but did not meet the primary safety endpoint of the PRO2TECT program, defined as non-inferiority vs. darbepoetin alfa in time to first occurrence of major adverse cardiovascular events.
Akebia and Otsuka are collaborating on the development and commercialization of vadadustat in the United States, Europe, China, Russia, Canada, Australia, the Middle East and certain other territories. In addition, Otsuka is working with Akebia to prepare a marketing authorization application for vadadustat for submission to the European Medicines Agency later this year, according to the release.
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