FDA AdCom votes against approving Reata's bardoxolone for Alport-caused CKD
The US Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee came up with a negative opinion following its meeting yesterday on bardoxolone methyl for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome.
The New Drug Application (NDA) for bardoxolone methyl for the treatment of patients with CKD caused by Alport syndrome was filed by US drugmaker Reata Pharmaceuticals (Nasdaq: RETA), whose share trading was suspended during the deliberations, but were down a massive 45% at $54.42 in pre-market ativity today.
The Committee voted no - by 13 to 0 - on the question of whether the provided evidence demonstrated that bardoxolone is effective in slowing the progression of CKD in patients with Alport syndrome and that its benefits outweigh its risks.
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