Innoviva Specialty Therapeutics Announces FDA Approval for XACDURO (sulbactam for injection; durlobactam for injection), Co-packaged for Intravenous Use - Seite 2

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). We anticipate that XACDURO will be available to patients later this year.

About Acinetobacter
Members of the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients often resulting in severe pneumonia and bloodstream infections.¹ They can also infect other body sites, such as the urinary tract and the skin. Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance. Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.

The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat.² Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019.³ Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO).⁴

In the U.S., there are an estimated 40,000 to 80,000 cases of Acinetobacter each year, and about 40 percent of those are carbapenem-resistant Acinetobacter.^5,6 Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii.⁵ More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter.⁷

About XACDURO
XACDURO (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, approved 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 not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter.