AMDAC Votes Unanimously in Favor of Possible Bacterial Pneumonia Therapy

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Infection Control TodayInfection Control Today, June 2023, (Vol. 27 No. 5)
Volume 27
Issue 5

Sulbactam-durlobactam is under priority review (PDUFA; May 29, 2023). 

Acinetobacter baumannii  (Adobe Stock, unknown)

Acinetobacter baumannii

(Adobe Stock, unknown)

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.

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