The FDA has issued a Complete Response Letter (CRL) regarding Reata Pharmaceuticals Inc's (NASDAQ: 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.
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