Testimony Before the FDA’s Cardiovascular and Renal Drugs Advisory Committee Regarding Bardoxolone Methyl for Slowing the Progression of Chronic Kidney Disease Caused by Alport Syndrome
In testimony before a meeting of the Food and Drug Administration’s (FDA’s) Cardiovascular and Renal Drugs Advisory Committee, Public Citizen urged the Committee to recommend that the FDA not approve bardoxolone methyl because the drug has well-established risks of serious harms but the pivotal phase 3 trial of the drug failed to provide substantial evidence that the drug slows the progression of chronic kidney disease in Alport syndrome patients. As a result, a favorable benefit-risk profile has not been established for bardoxolone.