FDA Approves Xacduro (sulbactam and durlobactam) for the Treatment of Serious Infections Caused by Acinetobacter

May 23, 2023 - Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved Xacduro ^® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). The FDA granted the approval of Xacduro to Entasis Therapeutics.

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 .

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.

The FDA approval was based on an array of scientific evidence, including results from the landmark Phase 3 ATTACK trial evaluating the safety and efficacy of Xacduro versus colistin in patients with infections caused by Acinetobacter. In the trial, Xacduro demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem- resistant Acinetobacter infections and a significant difference in clinical cure rates. Xacduro was well tolerated and exhibited a favorable safety profile across the clinical program.

The most common adverse reaction with Xacduro was liver function test abnormalities. Xacduro comes with certain warnings and precautions, such as hypersensitivity reactions and Clostridiodes difficile- associated diarrhea.

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.

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