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Tenacity

Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease

Tenacity

New England Journal of Medicine Publishes Results of Global Phase 3 Clinical Program of Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease

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Advancing new hope for
people with kidney disease

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challenging the status quo

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A trusted leader in the renal community delivering unique products to people with kidney disease.

We are a fully integrated biopharmaceutical company. Our team works to address complications of kidney disease. We have both a commercially available medicine and a late stage oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), vadadustat. Following the completion of our global Phase 3 clinical development program for vadadustat, we have now filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for U.S. regulatory approval for vadadustat for the treatment of anemia due to CKD for adult patients on dialysis and adult patients not on dialysis. Vadadustat and other HIF-PHIs are based on Nobel Prize-winning science.

Vadadustat is an investigational drug that has not been approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority for use outside of Japan. Within Japan, vadadustat is approved and marketed by Mitsubishi Tanabe Pharma Corporation under the trade name VAFSEO™ as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

Be part of a passionate team working to protect the kidneys and to innovate for better lives

Nearly 37 million Americans

are currently affected by chronic kidney disease.

Chronic kidney disease is a serious and life-altering illness that is persistent, progressive, and irreversible.

Reference
Centers for Disease Control and Prevention. Chronic Kidney Disease in the United States, 2019. Available at: https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html. Accessed: September 3, 2019.

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