FDA Approves Xacduro for Difficult-to-Treat Bacterial Pneumonia
2 Jun 2023 • The U.S. Food and Drug Administration approved Xacduro (sulbactam for injection; durlobactam for injection, a new 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.
Of those who received Xacduro, 19% (12 of 63 patients) died, compared to 32% (20 of 62 patients) who received colistin; this demonstrated that Xacduro was noninferior to colistin.
The most common adverse reaction with Xacduro was liver function test abnormalities. Patients should not receive Xacduro if they have a history of known severe hypersensitivity to components of Xacduro, sulbactam or other beta-lactam antibacterial drugs.
Source: FDA | Read full story