FDA denies formal dispute resolution for vadadustat, outlines path forward
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Key takeaways:
- Office of New Drugs denies formal dispute resolution for vadadustat.
- Akebia plans to request a type A meeting then resubmit new drug application in second half of 2023.
Akebia Therapeutics’ formal dispute resolution request was denied by the Office of New Drugs of the FDA for vadadustat in the treatment of anemia for dialysis-dependent patients, according to a press release.
However, the response letter provided a path forward for the company to resubmit the new drug application.
“The [Office of New Drugs] OND’s letter provides guidance on a path for the resubmission of our NDA and potential approval of vadadustat for dialysis-dependent patients in the U.S. without suggesting the need to generate additional clinical data,” John P. Butler, of Akebia, said in the release. “We appreciate the FDA's engagement with us throughout the appeal process.”
According to the release, the complete response letter in March 2022 outlined its analysis of the drug and potential issues, such as an increased risk of thromboembolic events driven by vascular access thrombosis (VAT). While not dismissing the potential safety signal, the OND indicated the extent of the increase in potential risk is not large and it may be a reasonable conclusion that the increase in VAT events can be managed as a labeling issue.
The complete response letter also noted concerns about risks drug-induced liver injury and the implementation of ongoing monitoring. The OND response letter concluded that “while drug-induced liver injury remains a concern, the signal appears modest in intensity and is potentially manageable with appropriate monitoring,” according to the release.
The OND response letter outlined a path forward to resubmit the drug for the treatment of dialysis-dependent patients, without the need to conduct new clinical studies, according to the release. It provided feedback on health concerns as well as potential resolutions, such as including post-approval data from Japan in its resubmission, where there have been no reports of liver damage in the more than 2 years that vadadustat has been on the market.
The European Commission and the United Kingdom Medicines and Healthcare Products Regulatory Agency also granted marketing authorization for vadadustat to treat symptomatic anemia associated with CKD in adults on chronic maintenance dialysis in April and May, respectively. Akebia also entered an exclusive license agreement with Germany-based Medice to market and sell the drug in the European Economic Area, in addition to the United Kingdom, Switzerland and Australia.
Akebia plans to request a type A meeting with the OND to ensure alignment on the contents of the NDA resubmission as soon as possible and expects to resubmit the NDA in the second half of 2023, according to the release.
“We remain committed to patients impacted by kidney disease and believe in the favorable balance of the benefits and risks of vadadustat as a treatment for anemia due to chronic kidney disease,” Butler said in the release.
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