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XACDURO®, The First and Only Antibiotic Developed to Target Acinetobacter, Now Available to Treat Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) in Adults
XACDURO is a new FDA-approved treatment used to fight against HABP/VABP infections caused by isolates of Acinetobacter baumannii-calcoaceticus complex, which
About this update from Innoviva, Inc.
[{"type":"text","content":"\n\nXACDURO is a new FDA-approved treatment used to fight against HABP/VABP infections caused by isolates of Acinetobacter baumannii-calcoaceticus complex, which can include those resistant to carbapenems (CRAB).\n\n\n\nIn the U.S., it is estimated there are more than 40,000 cases of Acinetobacter each year and approximately 40 percent are carbapenem-resistant.1,2\n\n\n\nPatients with HABP/VABP caused by Acinetobacter infections face high mortality and significant costs due to drug resistance and limited approved treatment options.\n\n\n\n WALTHAM, Mass.--(BUSINESS WIRE)--\nInnoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc. (Nasdaq: INVA), today announced that XACDURO® (sulbactam for injection; durlobactam for injection) is now available in the United States for 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).\n\n\n“XACDURO’s pathogen-targeted approach is a significant advancement in the way healthcare professionals treat Acinetobacter, one of the most serious antibiotic-resistant pathogens known to cause life-threatening pneumonia that is associated with high morbidity and mortality rates,” said Pavel Raifeld, Chief Executive Officer, Innoviva. “The addition of XACDURO to our portfolio of critical care medicines underscores our commitment to this space by providing healthcare professionals with differentiated therapeutic options to help improve patient outcomes.”\n\n\nXACDURO received regulatory approval from the U.S. Food and Drug Administration (FDA) in May 2023 and is now available by prescription through specialty pharmacy distributors in a healthcare setting. The FDA approval was based on strong scientific evidence, including results from the landmark Phase 3 ATTACK trial, published in The Lancet: Infectious Disease, evaluating the safety and efficacy of XACDURO versus colistin in patients with infections caused by Acinetobacter.3 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.3 XACDURO was well tolerated and exhibi...