Akebia Announces FDA Acceptance of Vadadustat Resubmission for Anemia

News
Article

The FDA has accepted Akebia Therapeutics' resubmission of the vadadustat NDA for anemia in chronic kidney disease. PDUFA date is March 27, 2024.

US FDA logo in black over a white background. | Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

The US Food and Drug Administration has acknowledged receipt of Akebia Therapeutics’ resubmission of their New Drug Application (NDA) for vadadustat in the management of anemia due to chronic kidney disease in adults patients on dialysis.

Acceptance of the resubmission, which was announced by Akebia Therapeutics on October 5, 2023, comes less than 2 years after the receipt of a Complete Response Letter in March 2022. According to Akebia Therapeutics, the FDA classified this as a class 2 response, which sets a PDUFA date for vadadustat of March 27, 2024.1,2

Key Highlights

  • Akebia Therapeutics' vadadustat NDA resubmission for anemia in chronic kidney disease was accepted by the FDA.
  • The FDA classified this as a class 2 response with a PDUFA date set for March 27, 2024.
  • Resubmission addressed prior concerns and included post-marketing safety data from over 10,000 patients in Japan.

"We're extremely pleased the FDA acknowledged our resubmission to our NDA for vadadustat was complete following our productive interactions over the past year. We look forward to working closely with the agency to finalize the review," said John P. Butler, Chief Executive Officer of Akebia.1 "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."

Akebia originally submitted a New Drug Application (NDA) for their oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor as a treatment of anemia due to chronic kidney disease in adult patients either with or without dialysis to the FDA in June 2021. The FDA issued a Complete Response Letter to Akebia Therapeutics in March 2022, with this decision based on data within the NDA not supporting a favorable risk-benefit assessment for vadadustat in dialysis and non-dialysis patients. The FDA cited specific concern over the agent’s failure to demonstrate noninferiority in major adverse cardiovascular events among the non-dialysis patients included in their phase 3 clinical program.2

According to the release from Akebia Therapeutics, resubmission to its NDA addressed the issues raised in the complete response letter and it included post-marketing safety data from more than 10,000 of patients in Japan where vadadustat has been approved for more than 3 years. At the time of writing, vadadustat is approved for use in 35 countries.1

References:

  1. Akebia receives FDA acceptance of resubmission to NDA of Vadadustat for the treatment of anemia due to chronic kidney disease. Akebia Therapeutics. October 25, 2023. Accessed October 25, 2023. https://ir.akebia.com/news-releases/news-release-details/akebia-receives-fda-acceptance-resubmission-nda-vadadustat.
  2. Akebia Therapeutics provides update on regulatory process for vadadustat. Akebia Therapeutics. March 30, 2023. Accessed October 25, 2023. https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-provides-update-regulatory-process
Related Videos
Video 2 - "COPD Traits Associated with Phenotypes"
Video 1 - "Why is COPD Important?"
HCPLive Five at APA 2024 | Image Credit: HCPLive
Video 4 - "Moderate/Severe/Uncontrolled Asthma Classification"
Video 3 - "Type 2 Inflammation and Biomarkers in Asthma"
Video 6 - "Evaluating Safety of Novel LDL Management Mechanism"
Video 5 - "Optimizing PCSK9 Inhibitors and Analyzing Plaque Reduction Data"
© 2024 MJH Life Sciences

All rights reserved.