FDA AdComm backs Innoviva bacterial pneumonia antibiotic

April 19, 2023

An FDA advisory committee unanimously voted to support the approval of Innoviva's intravenous antibiotic for the treatment hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.

The Antimicrobial Drugs Advisory Committee voted 12-0 in support of approval based on a favorable benefit-risk assessment of sulbactam-durlobactam for the treatment of adults with bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).

Infections caused by drug-resistant Acinetobacter are life-threatening conditions associated with high morbidity and mortality and long, expensive hospital stays. Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria. 

Innoviva picked up sulbactam-durlobactam, a lead asset, in last year's acquisition of Entasis Therapeutics — which is now a subsidiary company. The investigational drug is a combination of sulbactam, a beta-lactam antibacterial, and durlobactam, a beta-lactamase inhibitor.

The treatment's New Drug Application, filed by Entasis, was accepted and granted Priority Review by the FDA in November 2022, with a PDUFA target action date of May 29, 2023.

This is the second piece of good news for antibiotics shared this week. Earlier, GSK presented positive results from two pivotal phase 3 trials for gepotidacin, an investigational antibiotic for uncomplicated urinary tract infections — bringing the drugmaker a step closer to having the first in a new class of oral antibiotics for the indication in over 20 years.

Every year, more than 1.2 million people worldwide die from antibiotic-resistant infections, and if no action is taken, it’s estimated this number will grow to 10 million per year by 2050.