FibroGen announces FDA advisory committee to review roxadustat NDA tentatively scheduled for July 15, 2021 for the treatment of anemia of chronic kidney disease.- FibroGen

FibroGen, Inc. announced that the FDA has informed the Company 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 III 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.