The U.S. Food and Drug Administration (FDA) has approved Innoviva Specialty Therapeutics’ XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
“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,” said David Altarac, MD, chief medical officer, Innoviva Specialty Therapeutics.
“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 FDA approval was based on an array of scientific evidence, including results from the landmark Phase 3 ATTACK trial evaluating the safety and efficacy of XACDURO versus colistin in patients with infections caused by Acinetobacter. In the trial, XACDURO demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates. XACDURO was well tolerated and exhibited a favorable safety profile across the clinical program.
“Acinetobacter poses a significant danger to hospitalized 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,” stated Andrew F. Shorr, MD, MPH, MBA, clinical professor of Medicine, Georgetown University School of Medicine, Washington, D.C.
“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.”
The New Drug Application (NDA) for XACDURO was filed by Entasis Therapeutics Inc., an affiliate of Innoviva Specialty Therapeutics. XACDURO was granted Priority Review and designated as a Qualified Infectious Disease Product (QIDP).