Akebia Therapeutics, Inc., a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, announced that the company received an interim response from the U.S. Food and Drug Administration (FDA) to its Formal Dispute Resolution Request regarding the Complete Response Letter received in March 2022 for vadadustat, which had been submitted to the FDA as a treatment for anemia due to chronic kidney disease in adult patients.
Akebia met with the FDA in November to discuss its appeal and subsequently received a request for additional clarifying information from the Office of New Drugs, Center for Drug Evaluation and Research, which is deciding the appeal. Akebia remains engaged with the FDA and expects to submit the requested information to the FDA in January 2023. Based on FDA guidance, Akebia expects to receive a response to its appeal 30 days from the date Akebia submits the requested information.
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Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. The Company was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.
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 U.S. Food and Drug Administration (FDA). On March 29, 2022, the FDA issued a complete response letter to Akebia’s New Drug Application for vadadustat for the treatment of anemia due to chronic kidney disease (CKD). In November 2022, Akebia submitted a Formal Dispute Resolution Request focused on the favorable balance of the benefits and risks of vadadustat for the treatment of anemia due to CKD in adult patients on dialysis. Vadadustat is currently under review by the European Medicines Agency for the treatment of anemia due to CKD in adults. In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.
SOURCE: PR Newswire