Following a positive advisory committee vote last month, the US Food and Drug Administration (FDA) yesterday approved Xacduro (sulbactam for injection; durlobactam for injection), developed by Entasis Therapeutics, a subsidiary of Innoviva (Nasdaq: INVA).
Xacduro is cleared for the treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older.
According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, highlighting the high level of need for additional treatment options amid growing global resistance to antimicrobial medicines.
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