A Tale Of Two Advisory Panels: The Divergent Fates Of Pretomanid And Plazomicin
The TB Alliance and Achaogen both presented their drugs to US FDA's Antimicrobial Drugs Advisory Committee with small patient populations in pivotal trials. Why did one fare better than the other?
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Achaogen can take solace in US FDA's approval of the aminoglycoside antibacterial for the treatment of complicated urinary tract infections, but the limited use indication for bloodstream infections was rejected.
Plazomicin's BSI Indication Gets 'No' From Advisory Panel, But US FDA Still Might Approve Under LPAD Pathway
Achaogen should at least be reassured by advisory committee's unanimous 'yes' vote for plazomicin's cUTI indication.
Advisory committee will review applications for cUTI indication, which looks good, and the BSI indication, which looks fraught.