New Treatment for Certain Bacterial Pneumonia Approved by FDA
The FDA has approved a new treatment—sulbactam/durlobactam for injection—for patients aged 18 years and older for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) that is by the bacterium Acinetobacter baumannii-calcoaceticus complex (A. baumannii).
“The FDA is dedicated to supporting the development of safe and effective treatment options for infections caused by difficult-to-treat bacteria like [A. baumannii],” said Peter Kim, MD, MS, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research.
A. baumannii is a bacterium species that tops the list of critical bacterial pathogens that “pose the greatest threat to human health,” according to the World Health Organization. The newly approved treatment contains sulbactam (structurally related to penicillin) and durlobactam. Sulbactam functions by killing A. baumannii and durlobactam protects sulbactam from being degraded by enzymes produced by the bacteria.
The treatment’s approval follows a multicenter, active-controlled, open-label, non-inferiority clinical trial that tested its efficacy. In total, 177 adults hospitalized with pneumonia caused by carbapenem-resistant A. baumannii were included and received either sulbactam/durlobactam intravenously or colistin (a comparator antibiotic) for 14 days. Additionally, both cohorts received an additional antibiotic—imipenem/cilastatin—as background therapy for potential HABP/VABP pathogens.
Of those that received the approved treatment 12 of 63 patients (19%) died, compared to 20 of 62 patients (32%) who received the antibiotic. The results confirmed that sulbactam/durlobactam was noninferior to colistin.
The most commonly reported adverse reaction was liver function test abnormalities.
FDA approves new treatment for pneumonia caused by certain difficult-to-treat bacteria. News release. US Food and Drug Administration; May 23, 2023. Accessed August 24, 2023. www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pneumonia-caused-certain-difficult-treat-bacteria