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Achaogen Questioning Whether Others Will Pursue LPAD Pathway After Zemdri Misses Out

Executive Summary

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. 

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Antibiotics With Bacteria-Specific, Rather Than Site-Specific, Indication Headed To US FDA

Entasis is seeking a pathogen-specific approval for its antibiotic/beta lactamase inhibitor candidate rather than an indication specific the site of an infection. Achaogen’s earlier failure to do the same may have helped set a path.

Entasis Anticipates First FDA Approval Of Pathogen-Specific Antibacterial

With Phase III data showing non-inferiority to colistin, as well as nephrotoxicity superiority, Entasis thinks sulbactam/durlobactam will provide a new standard of care and succeed where Achaogen’s Zemdri failed.

Antibiotics: Leveraging Off-Label Efficacy Data Needed To Drive Appropriate Use, Reimbursement

Clinicians and sponsors want the US FDA to open up antibacterial labeling to include more data on efficacy against resistant pathogens and in other body sites, but regulatory restrictions may require a workaround in the form of rapid, peer-to-peer communications about the data on new products.

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