Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease
"We're extremely pleased the FDA acknowledged our resubmission to our NDA for vadadustat was complete following our productive interactions over the past year. We look forward to working closely with the agency to finalize the review," said
Akebia's resubmission to its NDA addressed the issues raised in the complete response letter. The filing included post-marketing safety data from tens of thousands of patients in Japan where vadadustat is approved and has been on the market for more than three years. Vadadustat is currently approved for use in 35 countries.
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is not approved by the
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