Plazomicin's BSI Indication Could Be First LPAD Drug – If Achaogen Can Convince US FDA Of Efficacy
Executive Summary
Advisory committee will review applications for cUTI indication, which looks good, and the BSI indication, which looks fraught.
You may also be interested in...
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?
Antibiotic Test Case: Will LPAD + Non-Inferiority = Approval For Plazominicin's BSI Indication?
US FDA Office of Antimicrobial Products Director Ed Cox explained to an advisory committee why a non-inferiority analysis could work in the context of an unmet need.
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.