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Akebia to lay off 42% of workforce, suspend trials after FDA drug rejection

Dive Brief:

  • Akebia Therapeutics will lay off 42% of its workforce after the Food and Drug Administration last month rejected its most advanced experimental drug, an anemia pill known as vadadustat. The company had 426 full-time employees at the end of 2021.


  • In a regulatory filing, Akebia said the job cuts are part of a plan to “refocus its strategic priorities” around Auryxia, a marketed kidney disease treatment the company acquired in a 2018 merger. The company expects the restructuring to save it $60 million to $65 million in net cash through the end of 2023.


  • Akebia also disclosed the FDA suspended clinical trials of vadadustat in children following its March 29 rejection. In that decision, the agency determined vadadustat didn’t have a “favorable benefit-risk assessment,” months after reaching a similar conclusion on a rival drug from FibroGen.


Dive Insight:

Drugmaker efforts to develop more convenient anemia medicines has resulted in job cuts and restructurings at two of the companies furthest along.

FibroGen was first. The company’s pill showed promise treating anemia associated with chronic kidney disease in multiple trials, findings that supported approvals in Europe and Japan. A large-scale cardiovascular study then revealed an association with a higher risk of heart problems than the injectable drug Aranesp, which led U.S. regulators to reject FibroGen’s medicine in August and demand more data.

FibroGen announced a restructuring in November, as well as a meeting with the FDA. It hasn’t determined its next steps in the U.S. and on a conference call in February the company said that topic remains a focus of ongoing discussions with its development partner, AstraZeneca.

Akebia now is taking a similar path. The company’s drug, like FibroGen’s, proved just as good as an injectable biologic at raising patients’ hemoglobin levels in clinical testing. However, safety concerns marred those findings and the company’s efforts to convince the FDA that the “totality of the data” supported approval were unsuccessful. As with FibroGen, the FDA required Akebia to run another trial.

With its U.S. future uncertain, Akebia now will lean on Auryxia revenue and potential sales royalties for its anemia pill in Europe, where it’s currently under review and rights are owned by Otsuka.

Still, Akebia’s time to capitalize on Auryxia, which it acquired when it merged with Keryx Pharmaceuticals in 2018, is running out. Generic versions could launch in 2025. While Auryxia sales grew by 10% to $142 million last year, they did not offset the company’s $325 million in operating costs.

The planned layoffs will reduce Akebia’s workforce by about 42% “across all areas of the company,” and are expected to be completed by the end of the second quarter. The job cuts are aimed at leaving Akebia with the same level of expenses as a “single commercial product company,” the company said in the filing.