The U.S. FDA released briefing documents ahead of a Dec 8th Advisory Committee meeting regarding Reata Pharmaceuticals' marketing application for kidney disease drug, bardoxolone, raising concerns about the pivotal trial's primary endpoint.
Texas-based Reata is using data from the phase 3 CARDINAL study to support its NDA for bardoxolone as a treatment for patients with chronic kidney disease caused by Alport syndrome, a disease that can cause damages to tiny blood vessels in kidneys.
In the briefing documents, the agency notes concerns over the clinical data submitted regarding the estimated glomerular filtration rate (eGFR) — a key measure of kidney function and the primary endpoint of the CARDINAL trial. "FDA review team does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure," wrote the agency.
In addition to the concerns with CARDINAL trial, the FDA says there are no data submitted from an animal model of Alport syndrome or other adequate and well-controlled clinical trials in AS or CKD that show that bardoxolone slows the loss of kidney function.
The drug's PDUFA date is scheduled for February 25, 2022.