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Sulbactam-durlobactam is under priority review (PDUFA; May 29, 2023).
On April 17, 2023, the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously in favor of Entasis Therapeutics’ antibacterial, as a first-of-its-kind treatment for adults with hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
“The sulbactam-durlobactam New Drug Application (NDA), filed by Entasis Therapeutics Inc., a wholly owned subsidiary of Innoviva, was accepted and granted Priority Review by the FDA in November 2022, with a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023,” according to the press release.
“There remains no standard of care for treating the potentially life-threatening infections caused by Acinetobacter baumannii-calcoaceticus complex, including multidrug-resistant and carbapenem-resistant strains,” David Altarac, chief medical officer of Entasis therapeutics, a wholly owned subsidiary of Innoviva, told Infection Control Today®. “The FDA Advisory Committee’s unanimous vote reinforces our belief that, if approved, sulbactam-durlobactam could become the first pathogen-targeted therapy for hospital-acquired and ventilator-associated bacterial pneumonia caused by this high-unmet-need pathogen.”
This vote is significant because the World Health Organization considers Acinetobacter a Priority 1 pathogen. Further, it has acquired resistance genes to nearly all antibiotics used to treat Gram-negative bacteria. These antibiotics include fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems. Currently, no antibiotic regimen exists to treat these often life-threatening conditions.
According to the press release, the AMDAC based its recommendation on the totality of scientific evidence, including results from the Phase 3 trial evaluating the safety and efficacy of sulbactam-durlobactam versus colistin in patients with infections caused by Acinetobacter. In the trial, the investigators noted that sulbactam-durlobactam demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections, and they said a noteworthy difference in clinical cure rates. Sulbactam-durlobactam also exhibited a favorable safety profile with a statistically significant lower rate of nephrotoxicity as measured by modified Risk–Injury–Failure–Loss and End-stage kidney disease (RIFLE) criteria. The FDA will consider the Committee’s recommendation when it makes a final determination.
Sulbactam-durlobactam is an intravenous, or IV, investigational drug that combines sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor, being developed for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. Sulbactam-durlobactam has been designated a Qualified Infectious Disease Product by the FDA, which aims to spur the development of new antibiotics for serious and life-threatening infections, according to the press release.