On May 23, 2023, the US FDA approved Innoviva’s new antibiotic therapeutic medicinal product, Xacduro (sulbactam-durlobactam), to treat ventilator-associated bacterial pneumonia (VABP) and hospital-acquired bacterial pneumonia (HABP) caused by Acinetobacter baumannii for patients aged 18 years and older.
Xacduro antibiotic is an IV therapeutic combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor. It is not recommended for treating VABP/HABP caused by pathogens.
“The US FDA is dedicated to anchoring the development of safe and promising therapeutic options for infections caused by Acinetobacter baumannii,” stated Peter Kim, MD, MS, director of the Division of Anti-Infectives in the Food and Drug Administration’s CDER. “This approval helps acknowledge an intense unmet medical need by availing an additional therapeutic option for certain sickest individuals in our country’s hospitals.”
In April, the US FDA’s Anti-infective Drugs Advisory Committee (AMDAC) voted 12-0 to recommend Xacduro.
Xacduro is a co-packaged medicinal product containing two drugs sulbactam for injection and durlobactam for injection. The approval was based on findings from the phase 3 trial known as the ATTACK trial, which assessed Xacduro antibiotic versus colistin in those with documented A baumannii HABP, VABP, ventilated pneumonia, or bacteremia; the maximum of patients had pneumonia as the baseline infection.
Xacduro comes as a kit that contains a single-dose vial of sulbactam 1 gram and two single-dose vials of durlobactam (0.5 gram in each vial). The product requires reconstitution and further dilution before IV infusion.
The approved Xacduro dosage is sulbactam 1 gram and durlobactam 1 gram every six hours given by IV infusion over three hours. The recommended period of treatment is 7-14 days. The dosing regimen needs to be adjusted as per renal function.