FDA approves Innoviva’s Xacduro for intravenous use
Betsy Goodfellow | May 24, 2023 | News story | Medical Communications | FDA, Infections and infestations, Innoviva, pneumonia
Innoviva Specialty Therapeutics, a subsidiary of Innoviva, has announced that the US Food and Drug Administration (FDA) has approved Xacduro (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use in adult patients over the age of 18 for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
These infections are caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
The FDA approval follows evidence from the landmark ATTACK phase 3 trial which assessed the safety and efficacy of Xacduro compared to colistin in patients with infections caused by Acinetobacter. Within this trial, Xacduro showed statistical non-inferiority compared to colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections as well as a significant difference in clinical cure rates. The drug was also generally well tolerated.
David Altarac, MD, CMO of Innoviva Specialty Therapeutics, commented: “Xacduro is the first pathogen-targeted therapy approved to treat HABP/VABP 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.”
Andrew F Shorr, MD, MPH, MBA, clinical professor of medicine at Georgetown University School of Medicine, Washington DC, US, added: “Acinetobacter poses a significant danger to hospitalised patients, who are generally very ill and particularly susceptible to infections. Effectively treating infections caused by drug-resistant Acinetobacter is a challenge and makes this patient population in high need of new, effective treatment options. 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.”
Betsy Goodfellow
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