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Nine Major Approval Decisions To Watch In Early 2022

 
• By Ayisha Sharma

Nine prominent drug candidates are awaiting an FDA approval decision in the next few months. With the help of Biomedtracker's Early 2022 Outlook Report, we take a look at the potential launches likely to shake up the market from HIV to wet AMD.

Exterior view of the headquarters of US Food and Drug Administration (FDA).
First Ever Approvals Are Expected For Some Indications. • Source: Alamy

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...

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