Akebia has resubmitted its NDA for vadadustat with postmarketing safety data from Japan, where it has been on the market for more than three years. The new review date is March 27, 2024.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2024, to review the resubmission of vadadustat to treat adults with anemia due to chronic kidney disease (CKD) in patients on dialysis.
Developed by Akebia Therapeutics, vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. It was designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues.
“With this significant milestone, we expect to have vadadustat available shortly following an approval and are preparing for a commercial launch in the second half of 2024 as we are eager to offer an alternative oral medication to U.S. dialysis patients if approved,” John P. Butler, CEO of Akebia, said in a press release
In March 2022, the FDA had issued a complete response letter in which regulators questioned the benefit-risk assessment of vadadustat for dialysis and non-dialysis patients. The FDA expressed concerns about safety, noting that the data submitted in the NDA did not show non-inferiority in major adverse cardiovascular events (MACE) in the non-dialysis patient population. They also pointed to the increased risk of thromboembolic events and the risk of drug-induced liver injury.
The resubmission includes postmarketing safety data from tens of thousands of patients in Japan where vadadustat is approved and has been in market for more than three years. In Japan, it is marketed by Mitsubishi Tanabe Pharma as Vafseo. Vadadustat is currently approved for use in 34 countries.
In May 2023, officials from Akebia said a letter from the Office of New Drugs had offered the company a path forward. Regulators indicated that thromboembolic events, driven by vascular access thrombosis (VAT), could be managed as a labeling issue. Additionally, the agency suggested that drug-induced liver injury could be managed with appropriate monitoring and requested data from commercial experience in Japan to assess the risk drug-induced liver injury. Akebia said in a press release that there have no reports of drug-induced liver injury in more than two years on the market in Japan.