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Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro

In financial distress last May, AstraZeneca spinout Entasis Therapeutics sold out to holding company Innoviva for $113 million. A year later—to the day—Innoviva’s subsidiary has scored its first FDA approval.

The U.S. drug regulator has signed off on Xacduro, a treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. Xacduro targets bacteria known as Acinetobacter baumannii, a pathogen that can cause infections in the blood, urinary tract and lungs (pneumonia).

Acinetobacter has high drug resistance and has been identified as a threat by the World Health Organization and the Centers for Disease Control and Prevention. The organizations have highlighted the need for additional treatment options amid growing global resistance to antimicrobial medicines.

Xacduro, which was co-developed by Zai Lab, is a combination of injected treatments sulbactam, a beta lactam antibiotic, and durlobactam, a broad-spectrum beta lactamase inhibitor that tamps down Acinetobacter’s resistance, allowing the antibiotic to take effect.

The approval comes after a 12-to-0 vote in favor of the application from the FDA’s Antimicrobial Drugs Advisory Committee last month. The co-packaged treatment will be available to patients later this year, Innoviva said.

The company’s FDA application was supported by a phase 3 trial that showed the combo treatment kept more patients alive over a 28-day span than colistin, a common antibiotic used as a last resort against multidrug-resistant Gram-negative infections. Xacduro was found in the study to be noninferior to colistin with a favorable safety profile and tolerability, according to investigators. The death rate in the Xacduro arm was 19% compared with 32% in the colistin group.

Xacduro also topped colistin in reducing nephrotoxicity, a rapid deterioration of kidney function associated with certain medications. Xacduro’s rate of nephrotoxicity was 13% compared with 38% for those on colistin. 

Entasis was spun out of AstraZeneca in 2015. When Entasis sold to Innoviva last year, the latter company already owned 60% of Entasis’ shares.

After hitting public markets in 2018 at a share price of $15, Entasis shares have remained below $4 for the past two years.  

The sale of Entasis underscored the struggle antibiotic-focused biotechs have faced as new treatments are quickly outpaced by the rate of resistance. In 2019, almost 5 million deaths were tied to antimicrobial resistance, outpacing deaths by HIV/AIDS or malaria, according to an analysis published in The Lancet.