MENU 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 READ OUR PRESS RELEASE ; 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. LEARN MORE Our Medicine Research & Development Be part of a passionate team working to protect the kidneys and to innovate for better lives JOIN US 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. Understanding Kidney Disease Patients & Families Medical Professionals News For the latest news from Akebia, visit our Investors page. VIEW ALL NEWS BC-0014 (v3.0) 4/21 Akebia Therapeutics, Inc. 245 First Street, Suite 1400 Cambridge, MA 02142 Driving Directions +1 617.871.2098 phone +1 617.871.2099 fax Contact Us © 2021 Akebia Therapeutics, Inc. All rights reserved. AURYXIA®, AKEBIA® Therapeutics and their associated logos are trademarks of Akebia and/or its affiliates. All other trademarks and registered trademarks, trade names and service marks referred to herein are the property of their respective owners. Akebia is not associated with or sponsored by the trademark owners. Terms of Use / Privacy Policy / Social Media Guidelines / Note Regarding Forward Looking Statements / Website by D&CO Our website uses cookies to improve usability. By using the website, you agree to the Cookie Policy. By clicking on the “Cookie Settings” link, you can adapt the use of cookies according to your preferences. Cookies Settings Accept Cookies