Akebia Therapeutics Received Interim Response to Appeal for Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease from the FDA
Akebia met with the FDA in November to discuss its appeal and subsequently received a request for additional clarifying information from the
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 an investigational new drug and is not approved by the
Statements in this press release regarding Akebia Therapeutics, Inc.'s (Akebia's) strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia's expectations with respect to when it will submit the information requested by the
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