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.
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Entasis Antibiotic Indication Changed Ahead Of FDA Panel, Ending Quest For First Pathogen-Specific Approval
Entasis’s sulbactam-durlobactam gets solid review from FDA ahead of its 17 April advisory committee meeting, but the company looks like it will have to settle for a narrower indication than it initially proposed.
Final guidance documents for bacterial vaginosis, vulvovaginal candidiasis, and uncomplicated urinary tract infections contain few changes from draft.
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.