BioCentury
ARTICLE | Regulation

FDA questions roxadustat’s safety ahead of Thursday adcom

Fibrogen will need to address thromboembolism risk for CKD compound 

July 13, 2021 11:59 PM UTC

During Thursday’s meeting to discuss FibroGen’s NDA for roxadustat, FDA’s Cardiovascular and Renal Drugs Advisory Committee plans to discuss whether the candidate’s cardiovascular safety risks could be addressed by modifying dosing or treatment monitoring protocols, and whether such modifications should be tested before approval. 

Roxadustat is under FDA review to treat anemia due to chronic kidney disease in both dialysis-dependent and non-dialysis-dependent adult patients. ...