FDA Denies Akebia’s Vadadustat Appeal but Suggests a Path Forward

Persisting first through an FDA complete response letter (CRL), and then through a denial of a formal dispute resolution request, Akebia Pharmaceuticals is now counting on Japanese postmarketing safety data to get vadadustat, its chronic kidney disease (CKD) anemia drug, over the finish line in the U.S.

The drug is approved in Japan and 32 other countries but lingering doubts about drug-induced liver injury (DILI) and blood clots have prevented it from getting the FDA’s approval. However, the CRL suggested that “commercial experience” with the drug might be enough to reconsider the NDA.

In a press statement, the company said it will refile an NDA with postapproval safety data from thousands of Japanese patients who have been exposed to vadadustat.

“Notably,” the company said, “there have been no reports of DILI in the more than two years that vadadustat has been on the market in Japan.”

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