The regulator approved Xacduro for treating hospital-acquired and ventilator-associated bacterial pneumonia. The NDA was filed by Entasis Therapeutics, which Innoviva acquired in 2022.
Pictured: FDA sign in front of building/Grandbrothers/Adobe Stock
Innoviva is set to make a quick return on investment as its recently acquired Entasis Therapeutics just snagged its first FDA approval for an antibiotic treatment for bacterial pneumonia.
Xacduro, the Entasis-developed therapy, is a combination of sulbactam and durlobactam co-packaged for intravenous use in hospital-acquired and ventilator-associated bacterial pneumonias caused by carbapenem-resistant Acinetobacter baumannii–calcoaceticus complex (ABC).
Infections caused by this strain are highly antibiotic-resistant and often fatal. The CDC ranked ABC at the highest-level on its bacteria and fungi threats report. Cases are estimated at 45,000 ABC infections in the U.S and 1 million globally each year. The bacteria forms a biofilm that allows it to survive for long periods, even in an otherwise sterilized hospital environment.
“Drug-resistant Acinetobacter can cause serious and even life-threatening infections that are associated with high morbidity and mortality, and long, expensive hospital stays, as the pathogen continues to acquire resistance genes for almost all antibiotics used to treat Gram-negative bacteria,” Innoviva CMO David Altarac said in a statement.
Xacduro is the first pathogen-targeted therapy to be approved for pneumonias caused by ABC. In the landmark Phase III ATTACK trial, the combo antibiotic was compared against the most effective available treatment for this type of infection, colistin.
Mortality after 28 days was 19% (12 of 63 patients) in the Xacduro arm versus 32% (20 of 62 patients) in the colistin group. Tolerability was much improved in patients receiving Xacduro. The trial showed significantly lower treatment-related adverse events compared to the colistin arm.
Sulbactam has been approved since the mid-1980s. Structurally related to penicillin, the sulbactam in Xacduro works to kill the bacteria while the durlobactam inhibits the enzymes produced by ABC that would otherwise destroy the antibiotic.
In April, the FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously in favor of Innoviva’s New Drug Application. The committee cited an issue with the limited size of the safety database, as only 158 patients have received the drug overall at its proposed dose and duration.
Previously a majority shareholder, Innoviva decided to seal the deal in 2022 by scooping up the rest of Entasis’ available shares for $2.20 per share.
The company’s press release stated Xacduro should be available to patients later this year.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
