What happened
Shares of Akebia Therapeutics (AKBA 0.71%) are plunging today, down 72.3% as of 11:15 a.m. EDT, after the company announced results from a late-stage study of vadadustat in treating anemia due to chronic kidney disease (CKD) in adult patients not on dialysis. While the experimental drug met the primary and secondary efficacy endpoints of the study, it didn't meet the primary safety endpoint.
So what
It's not surprising that investors bailed on the biotech stock after the late-stage results were announced. A drug isn't likely to be approved by the FDA if there are concerns that it isn't safe.
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However, Akebia said that it still plans to file for FDA approval of vadadustat. Why? CEO John Butler stated, "We believe the cardiovascular safety of vadadustat is supported by the totality of the data from our global Phase 3 program."
Vadadustat has been evaluated in two late-stage studies. The results from an earlier phase 3 trial of the drug in treating anemia due to chronic kidney disease (CKD) in adult patients on dialysis were overwhelmingly positive. Akebia thinks that it has a shot at winning FDA approval for vadadustat in both dialysis and non-dialysis settings based on the combined data from both studies.
Now what
Akebia and its partner, Japanese drugmaker Otsuka, plan to meet with the FDA before the end of 2020. The companies intend to submit for U.S. regulatory approval of vadadustat in the dialysis and non-dialysis indications "as early as possible next year."
