The FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has decided not to recommend the approval of roxadustat for the treatment of patients with chronic kidney disease-related anemia. The panel voted 13 to one against approving the treatment for patients who are not on dialysis and voted 12 to two against its approval for dialysis-dependent patients.
In December 2019, roxadustat manufacturer FibroGen and its partner AstraZeneca submitted a new drug application to the FDA, which the agency accepted in February 2020. However, days before the drug was set to be approved in December 2020, the FDA called for an advisory meeting of the CRDAC to review additional data.
“We became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors,” Enrique Conterno, CEO of FibroGen, said in a press release. “It is important to emphasize that this does not impact our conclusion regarding the comparability, with respect to cardiovascular safety of roxadustat to epoetin-alfa in dialysis-dependent patients and to placebo in non–dialysis-dependent patients.” However, he added, based on the analysis, it was not possible to conclude that roxadustat was superior to epoetin alfa in reducing the risk of major adverse cardiovascular events (MACE) or MACE+ (defined as MACE plus worsening or any procedure for peripheral vascular disease, hospitalization for angina, or performance of coronary revascularization) in patients with incident dialysis, or MACE+ in patients on dialysis.
Roxadustat is currently approved for both indications in China, Japan, Chile, and South Korea, and is under regulatory review in the E.U. The FDA has not announced when it will make its final decision regarding approval.