Akebia files new drug application for anemia drug
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Akebia Therapeutics Inc. has submitted a new drug application to the FDA for vadadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia in both adult patients on dialysis and not on dialysis.
The submission “marks a significant milestone not only for Akebia and our partners, but also for patients living with this disease,” John P. Butler, CEO of Akebia, said in a press release. “The NDA submission includes data from over 8,000 patients across 36 clinical trials of vadadustat,” he said.
Last September, Akebia said vadadustat reached primary and key secondary efficacy endpoints in phase 3 PRO2TECT cardiovascular outcomes studies, 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 (MACE).
Butler told Healio Nephrology that Akebia expects the FDA to look at data from both the dialysis and non-dialysis trials in the next 60 days as it determines whether the NDA is complete and acceptable for review. “For the dialysis-dependent population, we feel the INNO2VATE data was incredibly clear and compelling ... we feel very confident about that data and feel confident about having that product approved.
“We are cautious but confident in the way we talk about the non-dialysis population because we missed that primary MACE endpoint,” Butler said. “[W]e... would not be asking for that indication unless we have a belief there.”
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