Thursday, 01 June 2023

US FDA approves new treatment for pneumonia caused by certain difficult-to-treat bacteria

24 May 2023 | News

Xacduro's efficacy was established in a multicenter, active-controlled, open-label non-inferiority clinical trial in 177 hospitalized adults

image credit- shutterstock

image credit- shutterstock

The US Food and Drug Administration (FDA) has 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. The FDA has granted the approval of Xacduro to US-based Entasis Therapeutics, established in 2015 as a spin-out from and with initial funding from AstraZeneca.

According to the World Health Organisation, 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.

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. Xacduro is administered by intravenous infusion.

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.

The FDA granted Xacduro Fast Track, Qualified Infectious Disease Product and Priority Review designations for this application. 

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