FDA approves Innoviva bacterial pneumonia antibiotic

May 24, 2023

The U.S. FDA has approved Innoviva's intravenous antibiotic for the treatment hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, offering new hope for critically ill patients who have limited treatment options.

The pathogen-targeted therapy, branded as Xacduro, treats infections caused by drug-resistant Acinetobacter.

The approval follows the advise of an FDA advisory committee, which voted unanimously back in April to support the intravenous antibiotic based on a favorable benefit-risk assessment.

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 as a Qualified Infectious Disease Product (QIDP) in November 2022.

Xacduro is the first new antibiotic to win FDA approval this year. Back in April, 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.