Acinetobacter baumannii are a common cause of pneumonia in hospitals, and infections can be life-threatening.
Innoviva’s treatment consists of a drug, sulbactam, that’s similarly structured as the antibiotic penicillin, along with another compound, durlobactam, that helps protect it from degradation. It’s taken intravenously and is cleared for use in people aged 18 and older.
The FDA based its approval on results from a Phase 3 trial that enrolled 207 hospitalized participants who either received Xacduro or another, existing antibiotic called colistin. Trial data showed treatment with Xacduro was no worse than the comparison treatment when measuring death from any cause 28 days after treatment for a confirmed infection of drug-resistant Acinetobacter baumannii.