Akebia Therapeutics Announces Positive Top-Line Results from Global Phase 3 Program of Vadadustat for Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis

Upon successful completion of the Phase 3 program, which includes the PRO2TECT studies of vadadustat for the treatment of anemia due to CKD in adult patients not on dialysis that the Company expects to read out mid-2020, Akebia plans to submit to FDA an NDA for vadadustat for the treatment of anemia due to CKD in adult dialysis-dependent and non-dialysis dependent patients. In close coordination with its collaborator, Otsuka Pharmaceutical Co. Ltd., the Company also plans to submit a Marketing Authorization Application (MAA) to EMA. Akebia and Otsuka are collaborating on the development and commercialization of vadadustat in the US, Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories. A Japanese New Drug Application (JNDA) for vadadustat was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) in July 2019 by Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s development and commercialization collaboration partner in Japan for vadadustat.

Conference Call:
Akebia will host a conference call with slides today, Tuesday, May 5, 2020, at 8:30 a.m. Eastern Time to discuss its INNO2VATE data and its first quarter financial results. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 8464788. The call will also be webcast LIVE with slides and can be accessed via the Investors section of the Company’s website at https://ir.akebia.com/[3]

A replay of the conference call and the slides will be available two hours after the completion of the call through May 11, 2020. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 8464788. An online archive of the conference call can be accessed via the Investors section of the Company’s website at https://ir.akebia.com/[4].

About Akebia Therapeutics
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[5], which does not form a part of this release.

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