AKBA

Vadadustat (Inno2vate)

Anemia with Chronic Kidney Disease (CKD) undergoing dialysis

NDA Filing

Exp Date

2021

Amp Volatility Score

N/A

Catalyst Info & Data Links

TITLE: Vadadustat- INNO2VATE for dialysis patients with anemia related CKD NDA Filing

  • Clinical Trial (NCT02892149) Efficacy and Safety Study to Evaluate Vadadustat for the Maintenance Treatment of Anemia in Subjects With Dialysis-dependent Chronic Kidney Disease (DD-CKD) (INNO2VATE)


WHAT IS THE NEXT CATALYST EVENT?

  • NDA Filing


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • 2021


PRIOR DATA/EVENTS

PRESS RELEASES

MECHANISM OF ACTION 

  • Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) 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 recently completed its global Phase 3 development program for the treatment of anemia due to CKD. Vadadustat is not approved by the U.S. Food and Drug Administration (FDA) or any regulatory authority with the exception of Japan's Ministry of Health, Labour and Welfare (MHLW). In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

Updated by MV

Vadadustat, HIF, Akebia, AKBA, INNO2VATE, dialysis patients, anemia related CKD, chronic kidney disease, 

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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