Akebia gets FDA review date of March 2024 for anemia drug vadadustat
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Key takeaways:
- The FDA has accepted resubmission of a new drug application from Akebia Therapeutics for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat.
- The agency has set a review date for the drug.
The FDA has set a user fee goal date of March 27, 2024, for review of the oral hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat for the treatment of anemia in adults on dialysis.
“We’re pleased the FDA acknowledged our resubmission to our [new drug application] NDA for vadadustat was complete following our productive interactions over the past year,” John P. Butler, CEO of Akebia Therapeutics Inc., said in a press release. “We look forward to working closely with the agency to finalize the review.”
The class 2 response, as designated by the FDA, sets off a 6-month review from the date of resubmission of the oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), according to the release.
FDA acceptance of the resubmission comes after the agency turned down the first NDA by Akebia for the drug in March 2022, as the FDA cited concerns over vascular access complications and liver toxicity. Akebia resubmitted the NDA in early October 2023.
Akebia notes that its resubmission addresses issues raised in the FDA complete response letter, including post-marketing safety data from patients in Japan, where vadadustat is approved for adults who require dialysis, as well as those who do not.
Vadadustat is designed to mimic the physiologic effect of altitude on oxygen availability, which can lead to increased red blood cell production and improved oxygen delivery to tissues.
Vadadustat is approved for the treatment of anemia in adults on chronic maintenance dialysis in 35 countries, according to the release.
“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,” Butler said.
Reference:
Akebia receives FDA acceptance of resubmission to NDA of vadadustat for the treatment of anemia due to chronic kidney disease. https://ir.akebia.com/news-releases/news-release-details/akebia-receives-fda-acceptance-resubmission-nda-vadadustat. Published Oct. 25, 2023. Accessed Oct. 25, 2023.
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