FDA Gives Akebia Glimmer of Hope for Rejected CKD-Related Anemia Drug

 Akebia Therapeutics scored a long-awaited win Tuesday when it announced the FDA has granted a path forward for vadadustat in anemia associated with chronic kidney disease in dialysis-dependent patients, which will not require the company to submit new data. 

The news came as part of a response from the FDA’s Office of New Drugs regarding Akebia’s appeal for the agency to reconsider its March 2022 rejection of vadadustat. 

Though the FDA again rejected Akebia’s Formal Dispute Resolution Request, CEO John Butler said in a conference call Tuesday that the recent decision came after the company submitted additional analyses of the data during the appeal process.

Despite being approved in 33 countries, the FDA originally denied Akebia’s New Drug Application (NDA) for vadadustat due to safety concerns, including thromboembolic events and the risk of drug-induced liver injury. The agency also stated the data did not support a favorable benefit-risk assessment of vadadustat for dialysis and non-dialysis patients. At the time, the FDA said Akebia would need to conduct additional trials before it would consider another NDA. 

The new version of the NDA would target CKD patients on dialysis and would involve adding the risk for heart or liver-related side effects to the medicine’s labeling. The NDA will also include post-approval data from Japan, “where tens of thousands of Japanese patients with CKD have been exposed to vadadustat to date," according to Akebia's press release. 

The road has been anything but smooth for Akebia in the year since the agency denied the NDA. One week after the FDA’s decision, the company announced plans to lay off 42% of its workforce. A few months later, Akebia saw its partnership with Otsuka Pharmaceuticals, the company that originally helped it develop vadadustat, come to an abrupt halt, causing its stock to plummet. 

Per the agency’s suggestion, Akebia stated it plans to meet with the FDA as soon as possible and expects to file a new application in the second half of 2023. The company anticipates the FDA will conduct a 6-month review following the resubmission.

"We are extremely pleased with this outcome,” Butler said in a statement. “Our team will quickly prepare for a Type A meeting with the Division and, in parallel, continue to prepare our resubmission.”

https://www.biospace.com/article/akebia-to-resubmit-anemia-drug-application-to-fda-after-initial-rejection/