FDA Committee Votes in Support of Approving Sulbactam-Durlobactam


The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted 12-0 in favor of recommending this antibiotic and sets up a PDUFA target action date of May 29.

The opportunistic bacterial pathogen Acinetobacter baumannii has been shown to not only be resistant to penicillin but has also acquired resistance genes for almost all antibiotics used to treat gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.

An investigational antibiotic, sulbactam-durlobactam, developed by Entasis Therapeutics, which is a wholly owned subsidary of Innoviva, has been working its way through clinical trials for treatment of the resistant pathogen. The company completed its phase 3 studies for sulbactam-durlobactam last year and has made another step towards FDA approval.

Yesterday, the FDA AMDAC voted 12-0 in favor of recommending FDA approval for sulbactam-durlobactam for the indication of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii.

“The Committee’s unanimous recommendation in favor 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,” Entasis Chief Medical Officer David Altarac, MD, said in a statement.

Sulbactam-durlobactam is an intravenous, investigational drug that is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor.

The committee 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, 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 a significant difference in clinical cure rates.

Sulbactam-durlobactam also exhibited a favorable safety profile with a statistically significant lower incidence of nephrotoxicity as measured by modified Risk–Injury–Failure–Loss and End-stage kidney disease (RIFLE) criteria.

Alita Miller, PhD, senior vice president of research at Entasis Therapeutics, recently spoke to Contagion about sulbactam-durlobactam and the research being presented at this week’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

Next Steps
The FDA PDUFA date of May 29 is approximately 6 weeks away. “We appreciate the Committee’s thoughtful deliberation and strong vote of confidence, and look forward to working with the FDA as it completes its review,” Altarac said.

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