Sulbactam-durlobactam from Innoviva should be approved by the US FDA to treat ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia.

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The US Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) unanimously voted 12-0 in favour of approval of sulbactam-durlobactam for the treatment of adults with ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia caused by susceptible strains, according to an announcement from Innoviva, Inc., a diversified holding company with a portfolio of royalties and other healthcare assets. The FDA accepted and awarded Priority Review of the Entasis Therapeutics Inc.’s (a 100% owned subsidiary of Innoviva) sulbactam-durlobactam New Drug Application (NDA) in November 2022, with a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023.

According to David Altarac, MD, chief medical officer of Entasis Therapeutics, a fully owned subsidiary of Innoviva, “The Committee’s unanimous recommendation in favour of sulbactam-durlobactam, the first pathogen-targeted therapy for Acinetobacter, moves us closer to potentially addressing the urgent need for new treatment options for patients with serious and life-threatening infections caused by this pathogen.” We value the Committee’s careful consideration and unanimous support, and we look forward to cooperating with the FDA as it completes its evaluation.

The results of the historic phase 3 trial comparing the safety and effectiveness of sulbactam-durlobactam versus colistin in patients with Acinetobacter infections served as the foundation for the Committee’s decision. For the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections, the trial showed statistical non-inferiority for sulbactam-durlobactam over colistin, as well as a substantial difference in clinical cure rates. According to modified Risk-Injury-Failure-Loss and End-Stage Kidney Disease (RIFLE) criteria, sulbactam-durlobactam also shown a favourable safety profile with a statistically significant decreased incidence of nephrotoxicity. The FDA will evaluate the Committee’s suggestion before making a final decision.

Drug-resistant Acinetobacter infections are serious, potentially fatal illnesses that are accompanied by high rates of morbidity and mortality as well as extended, expensive hospital admissions. In addition to having gained resistance genes to nearly all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems, Acinetobacter is resistant to penicillins.

Microbes that are resistant to carbapenem have been classified as an urgent danger by the Centres for Disease Control and Prevention (CDC). Acinetobacter baumannii ranked among the top six infections worldwide for mortality brought on by resistance in 20193. Acinetobacter that is resistant to carbpenem is a Priority 1 pathogen according to the World Health Organisation (WHO).

Gram-negative, opportunistic human pathogens belonging to the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) typically infect critically ill individuals, frequently causing serious pneumonia and bloodstream infections. They can also spread infection to other parts of the body, including the skin and urinary tract. The propensity of Acinetobacter to develop multidrug resistance is one reason why it is seen as a global problem in the healthcare industry. We estimate that more than 300,000 hospital-treated carbapenem-resistant Acinetobacter infections occur each year in the world, with significant morbidity and mortality due to the lack of effective treatment options.

Sulbactam-durlobactam is an intravenous, or IV, investigational drug being developed for the treatment of ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter). Sulbactam is a beta-lactam antibacterial, and durlobactam is a beta-lactamase inhibitor. The FDA has recognised sulbactam-durlobactam as a Qualified Infectious Disease Product, a designation intended to encourage the development of fresh antibiotics for dangerous and lethal illnesses. The Prescription Drug User Fee Act (PDUFA) target date of May 29, 2023 was set by the FDA when it accepted the New Drug Application (NDA) for sulbactam-durlobactam for Priority Review in November 2022.

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