Reata Pharma gets CRL from FDA for bardoxolone

The US Food and Drug Administration on Friday issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for bardoxolone methyl for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome, said the drug’s developer, Reata Pharmaceuticals (Nasdaq: RETA), whose shares fell 3.7% to $25.16 in after-hours trading.

In December 2021, the FDA’s Cardiovascular and Renal Drugs Advisory Committee came up with a negative opinion following its meeting on bardoxolone methyl for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome.

The CRL indicates that the FDA cannot approve the NDA in its present form. Based on its review, the FDA concluded that it does not believe the submitted data demonstrates that bardoxolone is effective in slowing the loss of kidney function in patients with Alport syndrome and reducing the risk of progression to kidney failure and has requested additional data to support the efficacy and safety of bardoxolone. The agency’s conclusion was based on efficacy and safety concerns primarily set forth in the FDA’s briefing book and discussed at the Cardiovascular and Renal Drugs Advisory Committee meeting held on December 8, 2021.