United States: - The US Food and Drug Administration (FDA) has approved Xacduro (sulbactam for injection; durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of bacteria called Acinetobacter baumannii-calcoaceticus complex, for patients 18 years of age and older Sulbactam for injection and durlobactam for injection are both found in the co-packaged medication XACDURO. Adults with a creatinine clearance (CLcr) of 45 to 129 mL/min should take 1 gramme (g) of sulbactam and 1 g of durlobactam every 6 hours by intravenous (IV) infusion over a period of 3 hours. The drug XACDURO® (sulbactam for injection and durlobactam for injection), co-packaged for intravenous use, has received FDA approval, announced by Innoviva Specialty Therapeutics manufacturer of XACDURO.

In a multicenter, active-controlled, open-label, non-inferiority clinical trial involving 177 hospitalized people with carbapenem-resistant A. baumannii pneumonia, the effectiveness of Xacduro was determined. Patient were given either Xacduro or Colostin for 14 days. 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. 19% (12 of 63 patients) of those who received Xacduro died, compared to 32% (20 of 62 patients) of those who received colistin; this showed that Xacduro was noninferior to colistin.

Sulbactam, a medication chemically similar to penicillin, and durlobactam make up the medicine Xacduro. 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. If a patient has a history of severe hypersensitivity to Xacduro, sulbactam, or other beta-lactam antibacterial medications, they should not be prescribed Xacduro.

Unusual results on liver function tests were the most frequent adverse reaction to Xacduro. Precautions and warnings related to Xacduro include hypersensitivity reactions and Clostridiodes difficile-associated diarrhea.

According to Peter Kim M.D., M.S., Director of the Division of Anti-Infective in FDA’s Center for Drugs Evaluation and Research “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 and 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."

According to Keith S. Kaye MD, Master of Public Health (MPH) “I think sulbactam-durlobactam offers the first effective, safe option for these highly resistant strains of Acinetobacter that we’ve seen,” “The durlobactam basically restores the sulbactam activity and what you end up with is another first-line treatment option for Acinetobacter, as before we were using either unproven therapies, toxic therapies or therapies that had major limitations. So, this is a major step forward.”

According to David Altarac MD, Chief Medical Officer Innoviva Specialty Therapeutics “XACDURO is the first pathogen-targeted therapy approved to treat hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter. The FDA approval of XACDURO marks an important milestone in our aim to deliver differentiated therapies to critically ill patients who have limited treatment options,” “Drug-resistant Acinetobacter can cause serious and even life-threatening infections that are associated with high morbidity and mortality, and long, expensive hospital stays, as the pathogen continues to acquire resistance genes for almost all antibiotics used to treat Gram-negative bacteria.”

According to TechSci Research, Hospital acquired bacterial pneumonia and ventilator associated bacterial pneumonia are commonly observed forms of hospital acquired infections among the patients.  FDA’s approval of Xacduro will help in addressing high unmet medical needs of critically ill patients. Hospital-acquired pneumonia (HAP) is an infection of the lungs that occurs during a hospital stay. It is also known as nosocomial pneumonia. HAP is caused by bacteria, viruses, or fungi that are present in the hospital environment. These germs can be spread through the air, on hands, or on surfaces. The incidence of Hospital Acquired Pneumonia ranges from five to more than 20 instances per 1000 hospital admissions, and from 2.5 to more than 6.1 cases per 1000 patients not admitted to the intensive care unit (ICU). The approval of Xacduor is expected to have a positive impact on the market for hospital acquired infection control market and anti-bacterial drugs as well. The market for anti-bacterial drugs has been declining in recent years due to the increasing drug resistance. The approval of Xacduor could help to reverse this trend. Xacduor is expected to increase competition in the market for anti-bacterial drugs especially those used to treat Hospital Acquired Pneumonia (HAP) and Ventilator Acquired Pneumonia (VAP).