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Antibiotic Test Case: Will LPAD + Non-Inferiority = Approval For Plazominicin's BSI Indication?

 
• By Michael Cipriano

 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. 

Lily pad

The 21st Century Cures Act equipped the US FDA with the flexibility to approve antimicrobial drugs based on a limited population if the drug treats a life-threatening infection in a limited population of patients with unmet needs, creating with is known as the "LPAD" pathway. But can a non-inferiority analysis be used for an LPAD indication in the context of unmet needs?

It is possible, FDA officials say, at least in the context of Achaogen Inc.'s plazomicin

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