The FDA has rejected Cambridge, Mass.-based Akebia Therapeutics’ New D2rug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).
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Today, the FDA rejected Cambridge, Massachusetts-based Akebia Therapeutics’ New Drug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD). In its Complete Response Letter, the FDA stated that it was rejecting the application due to safety concerns.
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. The FDA’s concerns with the therapeutic include thromboembolic events and the risk of drug-induced liver injury, and it stated that the data does not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients.
The news came as a shock to many, including John P. Butler, CEO of Akebia. Butler used a priority review voucher to reduce the wait time for the FDA’s review. The company submitted its NDA exactly one year ago today.
“We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD. We continue to believe the data are supportive of a positive benefit-risk assessment of vadadustat for patients with anemia due to CKD, particularly in dialysis patients,” Butler said.
Though this news is a blow for Akebia, it is possible that the therapeutic could be approved in the future. In the CRL, the FDA said that the company could still show a favorable benefit-risk assessment through new clinical trials. Akebia addressed this in its press release.
“The CRL stated that Akebia could explore ways to potentially demonstrate a favorable benefit-risk assessment through new clinical trials. Akebia will discuss the details of the CRL with its collaboration partners and request a meeting with the FDA,” the company said.
Following the CRL, Akebia’s stocks reached a historic low, falling by over 65%. This news comes after the company amended its deal with Vifor in February, garnering $85 million in total for the drug’s expected launch.
This is not the first time the company has received negative feedback regarding vadadustat. Akebia’s shares plummeted in September of 2020 when it announced results for vadadustat from two Phase III clinical trials. Participants included adult patients with CKD who were not on dialysis, and the trial failed to meet multiple safety endpoints.
Vadadustat is approved in Japan for dialysis and non-dialysis dependent patients for the treatment of anemia caused by CKD. In October of 2021, Akebia and its partner, Otsuka Pharmaceutical, submitted an initial marketing authorization application (MAA) to the European Medicines Agency for vadadustat, and are currently still waiting for the European Medicine Agency’s decision.
