Complete Response Letters
Akebia Therapeutics, Inc.: vadadustat
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Mar 29, 2022
DD-CKD Trial 0016, ESA rescue for worsening anemia was reported in 22% of vadadustat-treated patients compared to 5% of darbepoetin alfa-treated patients.
CRL_NDA215192_20220329:p1:s23DILI can cause acute liver failure, the need for liver transplantation, or death.
CRL_NDA215192_20220329:p3:s11We expect these findings to be adequately mitigated with labeling when vadadustat can be approved, provided there are no concerning gastrointestinal findings in future clinical trials of vadadustat.
CRL_NDA215192_20220329:p4:s17More Complete Response Letters
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