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

 
• By Joseph Haas

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.

PS2110_Acinetobacter Baumannii_1200-BDGNT6 (Alamy)
Up close, Acinetobacter Baumannii may not look it much, but developing treatments has taken a lot of industry-regulator collaboration. • Source: Alamy

Entasis Therapeutics Holdings Inc. hopes to be the first company to obtain a pathogen-specific indication from the US Food and Drug Administration with a broad claim for its antibacterial combination product SUL-DUR to treat carbapenem-resistant Acinetobacterbaumannii infections, and it is relying on the agency’s flexibility regarding challenging disease areas with unmet medical need to get that done.

For its combination of the generic polymyxin antibiotic sulbactam with its novel beta-lactamase inhibitor durlobactam (SUL-DUR), the AstraZeneca PLC spinout appears to be working under a hybrid model based...

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