FibroGen Announces FDA Advisory Committee to Review Roxadustat New Drug Application Tentatively Scheduled for July 15, 2021

SAN FRANCISCO, April 06, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced that the U.S. Food and Drug Administration (FDA) has informed the Company late today it has tentatively scheduled a Cardiovascular and Renal Drug Advisory Committee (CRDAC) on July 15, 2021 to review the New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD) in both dialysis-dependent and non-dialysis-dependent patients.

The NDA submission was supported by positive results from a global Phase 3 program encompassing more than 8,000 patients. Roxadustat is approved and launched in China and Japan for the treatment of anemia of CKD in patients on dialysis and not on dialysis.

About Cardiovascular and Renal Drugs Advisory Committee
The Cardiovascular and Renal Drugs Advisory Committee (CRDAC) reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational drug products for use in the treatment of cardiovascular and renal disorders, and makes appropriate recommendations to the Commissioner of Food and Drugs. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of a product is made solely by the FDA.

About Anemia of CKD
Chronic kidney disease (CKD) is generally a progressive disease characterized by gradual loss of kidney function that may eventually lead to kidney failure or end stage renal disease, requiring dialysis or kidney transplant. CKD is estimated to occur in approximately 10-12% of adults worldwide and is predicted to become the fifth most common cause of premature death globally by 2040.

Anemia, a serious medical condition in which patients have insufficient red blood cells and low levels of hemoglobin, is a common early complication of CKD, affecting approximately 20% of CKD patients. Anemia of CKD is associated with an increased risk of hospitalization, cardiovascular complications, and death, and can also cause significant fatigue, cognitive dysfunction and reduced quality of life. Blood transfusions are used for treating severe anemia, however, they may reduce a patient’s opportunity for kidney transplant and can increase the risk of infection and/or complications such as heart failure and allergic reactions.