The Food and Drug Administration on Tuesday approved a combination drug for treating patients with bacterial pneumonia caused by the highly antibiotic resistant Acinetobacter baumannii-calcoaceticus complex.
The combo antibiotic, sulbactam-durlobactam (Xacduro), is indicated for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by these pathogens.
A. baumannii occurs most frequently in healthcare settings and typically causes pneumonia. It can cause infections in various parts of the body and is associated with a high rate of death. Current treatment options for drug-resistant A. baumannii are limited, the researchers said.
According to the World Health Organization, “acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health,” and new treatment options are much needed, the FDA noted in its announcement.
In clinical trials, 19% of patients who received Xacduro died, compared to 32% who received the antibiotic colistin, demonstrating that Xacduro was at least equally effective when compared to colistin. The most common adverse reaction to Xacduro was liver function test abnormalities, the FDA reported. The treatment also comes with warnings and precautions about potential side effects, including hypersensitivity reactions and Clostridioides difficile-associated diarrhea.
“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, MD, director of the division of anti-infectives in the FDA’s Center for Drug Evaluation and Research. “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.”
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