Innoviva Specialty Therapeutics has received approval from the US Food and Drug Administration (FDA) for XACDURO to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
Co-packaged with sulbactam and durlobactam injections, XACDURO is said to be the first pathogen-targeted therapy addressing Acinetobacter, including resistant strains.
It is intended for use in patients aged 18 years and older with HABP/VABP caused by Acinetobacter.
Innoviva Specialty Therapeutics chief medical officer David Altarac said: “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.”
The approval is based on results from the Phase III ATTACK trial designed to assess the efficacy and safety of XACDURO against colistin.
XACDURO showed a favorable safety profile throughout the clinical programme and was well tolerated.
In the study, XACDURO demonstrated statistical non-inferiority against colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections.
It also showed a significant difference in clinical cure rates.
An estimated 40,000 to 80,000 cases of Acinetobacter are reported in the US each year of which 40% are related to carbapenem-resistant Acinetobacter.
Georgetown University School of Medicine clinical professor Andrew Shorr said: “Acinetobacter poses a significant danger to hospitalised patients, who are generally very ill and particularly susceptible to infections.
“I’m encouraged by the approval of co-packaged sulbactam-durlobactam as it means physicians will soon have a novel therapeutic option that may help to address this urgent public health threat.”