FDA Approves Xacduro for Intravenous Use in Individuals With HAI Acinetobacter Infections

The FDA has approved sulbactam and durlobactam (Xacduro; Innoviva Specialty Therapeutics) for co-packaged intravenous use in individuals aged 18 years and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex.¹

Argus - stock.adobe.com

“[Sulbactam and durlobactam for intravenous use] is the first pathogen-targeted therapy approved to treat hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter. The FDA approval of [sulbactam and durlobactam for intravenous use] 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 at Innoviva Specialty Therapeutics, in a statement.¹

The approval was based on an array of results, including those from the landmark phase 3 ATTACK trial (NCT03894046), which evaluated the safety and efficacy of sulbactam and durlobactam for intravenous use compared to colistin in individuals with infections caused by Acinetobacter.¹

The trial demonstrated that sulbactam and durlobactam for intravenous use showed statistical non-inferiority compared to colistin for the primary endpoint of 28-day all-cause mortality in individuals who had carbapenem-resistant Acinetobacter infections. It also demonstrated a significant difference in clinical cure rates.¹

Sulbactam and durlobactam for intravenous use were also well tolerated and provided a favorable safety profile across the clinical program, according to the statement.¹

The new drug application was filed by Entasis Therapeutics Inc, which is an affiliate of Innoviva Specialty Therapeutics. The drug was granted priority review and designated as a qualified infectious disease product and is expected to hit the market later in 2023.¹

“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,” Altarac said in the statement.¹

Acinetobacter are gram-negative human pathogens that infect individuals who are critically ill, which normally results in severe pneumonia and bloodstream infections.¹ The CDC reported that in 2017 an estimated 8500 infections of carbapenem-resistant Acinetobacter occurred in the United States. The agency noted that there were an estimated 700 deaths as well.²

Individuals who are most at risk for infection include those who are in the hospital, and particularly those who are on ventilators, have catheters, have open wounds from surgery, are in the intensive care unit, or experience prolonged hospital stays.²

While infections rarely occur outside of hospitals, the CDC notes that those who have weakened immune systems, chronic lung disease, or diabetes could be more susceptible.²

Although Acinetobacter infections are treated with antibiotics, the CDC has noted that many Acinetobacter infections are resistant to antibiotics, such as carbapenems, making them more difficult to treat.²

Reference

1. Innoviva Specialty Therapeutics announces FDA approval for Xacduro (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use. News release. Business Wire. May 23, 2023. Accessed May 24, 2023. https://www.businesswire.com/news/home/20230523005961/en

2. Centers for Disease Control and Prevention. Acinetobacter. Healthcare-Associated Infections (HAIs). Updated November 13, 2019. Accessed May 24, 2023. https://www.cdc.gov/hai/organisms/acinetobacter.html