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Akebia Therapeutics gets complete response letter from the FDA for vadadustat for CKD-associated anemia

By Brian Buntz | March 31, 2022

Akebia/OtsukaThe biopharma Akebia Therapeutics (Nasdaq:AKBA) has received a dreaded complete response letter from FDA for vadadustat, the experimental oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor proposed as a treatment for anemia associated with chronic kidney disease (CKD).

A complete response letter communicates the agency’s rejection of an application in its present form. In the case of vadadustat, the FDA rejected the drug candidate due to safety concerns. Specifically, the agency decided the new drug application (NDA) for vadadustat did not support a favorable benefit-risk assessment for dialysis and non-dialysis patients.

In particular, the FDA was concerned about the drug candidate’s potential association with major adverse cardiovascular events (MACE), vascular access thrombosis in dialysis patients and drug-induced liver injury.

Akebia submitted an NDA for vadadustat for anemia associated with CKD in March 2021. The company announced that FDA had accepted the application in June.

AKBA shares fell 14.04% in mid-day trading to $0.71.

FDA recommended strategies Akebia could pursue in new clinical trials to show a beneficial benefit-risk assessment.

“We are extremely disappointed to receive a CRL for vadadustat, a therapy that has the potential to help patients with anemia due to CKD. 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,” said John P. Butler, Akebia CEO, in a statement. “Despite this setback, we continue to work toward our purpose to better the lives of people impacted by kidney disease.”

Akebia developed vadadustat in collaboration with Otsuka Pharmaceutical Co. Otsuka is pursuing authorization for the drug candidate in the European Union.

Vadadustat is already approved in Japan as a treatment for anemia due to CKD regardless of dialysis dependence.


Filed Under: clinical trials, Drug Discovery, Hematology, Nephrology/urology

 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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