U.S. FDA Approved Intravenous Infusion for Bacterial Pneumonia
The U.S. Food and Drug Administration today approved Entasis Therapeutics's Xacduro, an intravenous infusion 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 adult patients 18 years of age and older.
"The FDA is dedicated to supporting the development of safe and effective treatment options for infections caused by difficult-to-treat bacteria like Acinetobacter baumannii-calcoaceticus complex," said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA's Center for Drug Evaluation and Research, in a press release on May 23, 2023.
"Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."
According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health.
Acinetobacter baumannii-calcoaceticus complex (hereafter referred to as A. baumannii) includes four species of bacteria in the Acinetobacter family.
These bacteria can cause infections in various body parts, occurring most frequently in healthcare settings and predominantly causing pneumonia.
A. baumannii can become highly resistant to multiple antibacterial drugs, and current treatment options for drug-resistant A. baumannii are limited.
Xacduro consists of sulbactam, a drug structurally related to penicillin, and durlobactam.
Sulbactam kills A. baumannii, whereas durlobactam protects sulbactam from being degraded by enzymes that may be produced by A. baumannii.
Previously, the FDA granted Xacduro Fast Track, Qualified Infectious Disease Product, and Priority Review designations for this application.
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