FDA Strikes Off Reata Pharma's Bardoxolone Application For Rare Kidney Disease

The FDA has issued a Complete Response Letter (CRL) regarding Reata Pharmaceuticals Inc's RETA application seeking approval for bardoxolone methyl for chronic kidney disease (CKD) caused by Alport syndrome.

• The agency concluded that it does not believe the submitted data demonstrates that bardoxolone effectively slows the loss of kidney function and reduces the risk of progression to kidney failure.
• The FDA has requested additional data to support the efficacy and safety of bardoxolone. 
• In December, The FDA's Cardiovascular and Renal Drugs Advisory Committee voted that the agency should not approve Reata's bardoxolone methyl capsules.
• In addition, the FDA needs the company to address whether bardoxolone has a clinically relevant effect on the QT interval and show that the demonstrated clinical benefits of bardoxolone outweigh its risks. 
• Alport syndrome is a rare, genetic form of CKD caused by mutations in the genes encoding type IV collagen, a major structural component of the glomerular basement membrane in the kidney. 
• Price Action: RETA shares closed higher by 2.15% at $26.13 on Friday.