After high-profile snub, Akebia plots vadadustat resubmission at FDA

After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for a second bid at approval.

Akebia plans to resubmit its application for vadadustat for anemia due to chronic kidney disease in adult patients on dialysis by the end of the third quarter, the company said Thursday. Akebia then expects the FDA to set an approval decision date six months out from the date of submission.

Akebia added that it had a “productive and informative” discussion with the FDA about its resubmission plan last month.

After the FDA handed Akebia a complete response letter last March, the company in October 2022 filed a formal complaint to dispute the FDA’s decision.

The FDA rejected the drug over safety concerns around vadadustat’s cardiovascular risks and liver injuries.

Outside the U.S., vadadustat is approved in 34 countries, including Japan, where the drug carries the Vafseo moniker. The drug was also approved by the European Commission in late April.

Vadadustat is part of a class of drugs called hypoxia-inducible factor–prolyl hydroxylase inhibitors (HIF-PHI). Once considered a potentially convenient alternative to erythropoiesis-stimulating agents (ESAs), safety concerns have blunted the class’s trajectory at the FDA. GSK in February snatched the first FDA nod for the class with Jesduvroq in dialysis patients only.

But Vadadustat’s rejection came as a major blow for Akebia last year. 

“I want to express my extreme disappointment and frustration at this outcome,” Akebia CEO John Butler said on a conference call at the time of the rejection. “Our team is deeply aware of the unmet needs of CKD patients with anemia, and we’re disheartened that we can not deliver a therapeutic that we believe could address those needs.”

To make matters worse for Akebia, its partner Otsuka decided to terminate licensing deals covering vadadustat for chronic kidney disease anemia for the U.S., Europe and other regions.

If the FDA reverses its decision and approves vadadustat in dialysis patients, Akebia plans to market it under an existing deal with CSL Vifor.