Approval is for hospital-acquired bacterial or ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus<\/em> complex<\/p>\n<\/h3>\n By Lori Solomon HealthDay Reporter<\/b><\/p>\n <\/b><\/p>\n TUESDAY, May 30, 2023 (HealthDay News) — The U.S. Food and Drug Administration has approved Xacduro (sulbactam for injection; durlobactam for injection) as a new treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus<\/em> complex (A. baumannii<\/em>).<\/p>\n Xacduro is administered via intravenous infusion and consists of sulbactam, a drug structurally related to penicillin, and durlobactam. It was approved under fast track, priority review.<\/p>\n The approval was based upon a multicenter active-controlled, open-label (investigator-unblinded, assessor-blinded), noninferiority clinical trial in 177 hospitalized adults with pneumonia caused by carbapenem-resistant A. baumannii<\/em>. Nineteen percent of patients receiving Xacduro died versus 32 percent of those who received colistin. The most common adverse reaction associated with Xacduro was liver function test abnormalities.<\/p>\n “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<\/em> complex,” Peter Kim, M.D., director of the Division of Anti-Infectives in the FDA Center for Drug Evaluation and Research, said in a statement. “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.”<\/p>\n Approval of Xacduro was granted to Entasis Therapeutics.<\/p>\n