Akebia resubmits application for vadadustat to treat anemia in patients on dialysis
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Key takeaways:
- Akebia Therapeutics resubmitted a new drug application to the FDA for its oral hypoxia-inducible factor prolyl hydroxylase inhibitor.
- The FDA turned down the first NDA by the company for the drug in 2022.
Akebia Therapeutics Inc. has resubmitted its new drug application to the FDA for vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor for the treatment of anemia in adults on dialysis.
“We are pleased to have resubmitted the NDA for vadadustat following multiple discussions with the FDA and clear direction from the agency, a significant milestone that reflects our team's commitment to patients and conviction in the benefit we believe vadadustat can deliver to patients on dialysis,” John P. Butler, CEO of Akebia, said in a press release. “Our team assembled a comprehensive resubmission, which now includes post-marketing safety data from tens of thousands of patients in Japan where vadadustat is approved and has been in market for more than [3] years. We look forward to working with the FDA during the review process and are eager to offer a new oral therapeutic to patients if approved.”
The FDA turned down the first NDA by the company for the drug in March 2022, citing concerns about vascular access complications and liver toxicity.
“We are extremely disappointed to receive a [complete response letter] CRL for vadadustat, a therapy that has the potential to help patients with anemia due to [chronic kidney disease] CKD,” Butler said in a press release at the time. “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.”
New submission
Akebia said based on standard NDA resubmission review timelines, “a letter from the FDA acknowledging that the resubmission is complete, classifying the resubmission, and setting the [Prescription Drug User Fee Act] PDUFA date is expected in 30 days,” according to the release. “Akebia expects the FDA to set a PDUFA date of [6] months from the date of submission.”
Vadadustat is approved in 35 countries in Europe and Australia for the treatment of symptomatic anemia due to CKD in adults on chronic maintenance dialysis and in Japan as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adults, according to the release.
In May, Akebia entered into an exclusive license agreement with Medice Arzneimittel Pütter GmbH&Co.KG, granting Medice the rights to market and sell vadadustat (Vafseo) in the European Economic Area, the United Kingdom, Switzerland and Australia. Under the terms of the agreement, Akebia recognized an upfront payment of $10 million and is eligible for commercial milestone payments up to an aggregate of $100 million and tiered royalty payments ranging from 10% to 30% of net sales of Medice, according to a press release.
Reference:
Akebia Therapeutics reports second-quarter 2023 financial results and recent business highlights. https://ir.akebia.com/news-releases/news-release-details/akebia-therapeutics-reports-second-quarter-2023-financial. Published Aug. 25, 2023. Accessed Oct. 3, 2023.
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