Plazomicin's BSI Indication Gets 'No' From Advisory Panel, But US FDA Still Might Approve Under LPAD Pathway

 
• By Michael Cipriano
  
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Achaogen should at least be reassured by advisory committee's unanimous 'yes' vote for plazomicin's cUTI indication. 

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Which of the proposed indications for Achaogen's plazomicin will flower?

The US FDA's Antimicrobial Drugs Advisory Committee voted 11 to 4 that Achaogen Inc.'s plazomicin sulfate injection did not show substantial evidence of safety and efficacy for the treatment of bloodstream infections (BSIs) in patients with limited or no treatment options, but the agency still might approve the aminoglycoside antibiotic for the indication under the 21st Century Cures Act's limited population (LPAD) pathway.

Several of the "no" voters for the BSI indication expressed that they were reluctant with their final decision, but they...

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