The New Drug Application (NDA) for vadadustat, an investigational therapy for anemia due to chronic kidney disease (CKD), has been submitted to the Food and Drug Administration (FDA).

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. This results in increased red blood cell production and improved oxygen delivery to tissues.

The NDA submission includes data from 36 clinical trials involving over 8000 patients. Findings from the INNO2VATE program, which included 2 open-label, active-controlled phase 3 trials, showed that vadadustat was noninferior to darbepoetin alfa in adult patients on dialysis with anemia due to CKD. Similar efficacy results were observed in the phase 3 PRO2TECT randomized trials in patients with anemia due to non-dialysis dependent CKD.

However, safety findings from the PRO2TECT trials contrasted with those in the INNO2VATE trials with regard to major adverse cardiovascular events (MACE; defined as all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke). Both INNO2VATE studies met the primary safety endpoint of noninferiority for MACE, while the combined data from PRO2TECT showed a 17% increased risk of MACE with vadadustat.


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“The submission of the vadadustat NDA for the treatment of anemia due to CKD in both adult patients on dialysis and not on dialysis marks a significant milestone not only for Akebia and our partners, but also for patients living with this disease,” said John P. Butler, Chief Executive Officer of Akebia. “We look forward to working with the FDA during the review process, and are excited to continue collaborating with our partners to advance vadadustat for the benefit of patients, subject to regulatory approval.”

Reference

Akebia submits New Drug Application (NDA) to the FDA for vadadustat for the treatment of anemia due to chronic kidney disease in adult patients on dialysis and not on dialysis. [press release]. Cambridge, MA: Akebia: March 30, 2021.