The U.S. Food and Drug Administration (FDA) has approved a drug designed to treat pneumonia caused by certain difficult-to-treat types of bacteria.
The FDA issued final approval to Entasis Therapeutics for Xacduro, which is administered intravenously to treat "hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus comple," a May 23 FDA press release said. Entasis was granted Fast Track, Qualified Infectious Disease Product and Priority Review designations for their application.
“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,” Dr. Peter Kim, director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research, said in the release. “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.”
The World Health Organization noted that Acinetobacter species are the most dangerous bacterial infections to human health, underscoring the crucial need for additional treatment options as antimicrobial drug resistance spreads globally.
The A. baumannii classification includes four species of bacteria in the Acinetobacter family, the release said. The bacteria occurs most commonly in health care settings and predominantly causes pneumonia. The bacteria can become highly resistant to antibacterial drugs, and current treatment options for drug-resistant A. baumannii are limited.
Sulbactam, a medication chemically similar to penicillin, and durlobactam make up the medicine Xacduro, the release said. While durlobactam shields sulbactam from being broken down by enzymes that A. baumannii might create, sulbactam kills A. baumannii. Xacduro is given intravenously by infusion. In a multicenter, active-controlled, open-label, non-inferiority clinical trial involving 177 hospitalized patients with carbapenem-resistant A. baumannii pneumonia, the effectiveness of Xacduro was determined. For up to 14 days, patients either got Xacduro or colistin, an antibiotic used as a comparison. Additionally, as background therapy for suspected HABP/VABP infections other than the Acinetobacter baumannii-calcoaceticus complex, both treatment groups also received the antibiotic combination imipenem/cilastatin. In patients with a proven infection with carbapenem-resistant A. baumannii, mortality from all causes within 28 days of treatment served as the main indicator of efficacy.
The most common adverse side effects of Xacduro are liver function test abnormalities, the release said. Users of Xacduro should be aware of hypersensitivity reactions and Clostridioides, a difficile-associated diarrhea. Patients should not take Xacduro if they have a history of severe hypersensitivity reactions to the components of Xacduro, sulbactam or other beta-lactam antibacterial drugs.
As part of the U.S. Department of Health and Human Services, the FDA is responsible for ensuring the safety, effectiveness and security of medicinal drugs, medical devices, vaccines and other biological products for human and veterinary use.
