FDA panel votes against use of Roxadustat for anaemia in CKD patients

The Committee backed its recommendation on a pool of information from a global Phase 3 program including more than 8,000 patients.

Chronic kidney disease (CKD) is usually a progressive disorder characterized by complete loss of kidney function that may ultimately cause kidney failure or end-stage renal disease, requiring dialysis or kidney transplant. While, anemia, which is a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is often an early complication of CKD, affecting at least 20 percent of CKD patients.

While, Roxadustat, is an orally administered drug, the first in a new class of medicines, HIF-PH inhibitors that promote erythropoiesis (red blood cell production), through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. It is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in adult patients on dialysis (DD) as well as not on dialysis (NDD).

Enrique Conterno, Chief Executive Officer, FibroGen, was quoted as, "While we are disappointed with today's outcome, we believe the scientific evidence supports roxadustat approval in the U.S. and will work with the FDA as it completes its review of the New Drug Application for roxadustat."

While for the FDA it is not mandatory to accept the Committee's vote, they do consider the Committee's non-binding recommendations when making their decision.

For more information refer to:

FibroGen announces outcome of FDA advisory committee review of roxadustat for treatment of anemia of chronic kidney disease. News release. FibroGen. Accessed on July 17, 2021. https://www.globenewswire.com/news-release/2021/07/15/2264019/33525/en/FibroGen-Announces-Outcome-of-FDA-Advisory-Committee-Review-of-Roxadustat-for-Treatment-of-Anemia-of-Chronic-Kidney-Disease.html.