Nine Major Approval Decisions To Watch In Early 2022

Reata Pharmaceuticals, Inc.’s bardoxolone for chronic kidney disease due to Alport syndrome is expected to get a US Food and Drug Administration thumbs down by its 25 February PDUFA date, following a negative advisory committee vote in December. The regulator claimed Reata had not adequately shown the drug could slow progression of kidney function decline in Alport syndrome, a rare condition characterized by kidney disease, hearing loss and eye abnormalities. (Also see "Reata’s Bardoxolone Shot Down, But US FDA Advisors Offer Suggestions For Improved Study" - Pink Sheet, 9 December, 2021.)

Bardoxolone increases the activity of the NRF2 transcription factor, which is key in the regulation of inflammation and intracellular redox homeostasis. In the Phase II/III CARDINAL study primary endpoint, the...