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Today, the U.S. Food and Drug Administration announced Zacduro (sulbactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by a susceptible bacterial strain called Acinetobacter baumannii. , durobactam for injection). – Calco acetic complex, for patients 18 years and older.
According to the World Health Organization, Acinetobacter tops the list of serious bacterial pathogens that pose the greatest threat to human health, and the need for additional treatment options is high as global resistance to antimicrobials increases. I’m highlighting that.
“The FDA is dedicated to helping develop safe and effective treatment options for infections caused by difficult-to-treat bacteria, such as the Acinetobacter baumannii calcoacetic acid complex,” said U.S. Anti-Infectives. said Peter Kim, M.D., director of the disease department. FDA’s Center for Drug Evaluation and Research. “Today’s approval helps address a high unmet medical need by providing additional treatment options for some critically ill patients in our nation’s hospitals.”
The Acinetobacter baumannii-calcoaceticus complex (hereafter referred to as A. baumannii) includes four members of the Acinetobacter family. These bacteria can cause infections in different parts of the body and most frequently occur in medical settings, primarily causing pneumonia. A. baumannii can be highly resistant to multiple antibiotics, and current treatment options for drug-resistant A. baumannii are limited.
Zacduro consists of sulbactam and durobactam, drugs that are structurally related to penicillins. Sulbactam kills her A. baumannii, while durobactam prevents sulbactam from being broken down by enzymes that may be produced by her A. baumannii. Zacduro is given by intravenous infusion.
The efficacy of Zacduro was non-inferior to a multicenter, active-controlled, open-label (investigator-blinded, evaluator-blinded) study in 177 hospitalized adults with carbapenem-resistant A. baumannii pneumonia. Established in clinical trials. Patients received either zacduro or colistin (comparison antibiotic) for up to 14 days. Both treatment groups also received the additional antibiotic imipenem/cilastatin as background therapy for potential HABP/VABP pathogens other than the Acinetobacter baumannii calcoacetic acid complex. The primary measure of efficacy was all-cause mortality within 28 days after treatment in patients with confirmed infection with carbapenem-resistant A. baumannii. Of patients receiving Zacduro, 19% (12 of 63 patients) died, compared with 32% (20 of 62 patients) of patients receiving colistin. This demonstrated that Xacduro is non-inferior to colistin.
The most common side effects of Zacduro were liver function test abnormalities. Zacduro comes with specific warnings and precautions, including hypersensitivity reactions and Clostridioides- and difficile-associated diarrhea.
Patients with a history of known severe hypersensitivity to zacduro, sulbactam, or other beta-lactam antibiotic components should not receive zacduro.
The FDA has granted Xacduro Fast Track, Qualified Infectious Disease Product, and Priority Review designations for this application.
The FDA has granted Entasis Therapeutics approval for Xacduro.
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FDA, an agency within the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and security of human and animal drugs, vaccines and other biological products for humans, and medical devices. is protecting The agency is also responsible for regulating our country’s food supply, cosmetics, dietary supplements, the safety and security of electronic radiation emitting products, and tobacco products.