AstraZeneca-Spin Off Entasis Secures FDA Approval For First Pathogen-Targeted Therapy Addressing Acinetobacter

Innoviva Inc's INVA affiliate Entasis Therapeutics Inc received FDA approval for Xacduro (sulbactam and durlobactam for injection), co-packaged as a treatment for hospital-acquired pneumonia.
The approval covers patients 18 years and older for hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by difficult-to-treat bacteria strains known as Acinetobacter baumannii-calcoaceticus complex.
Innoviva acquired Entasis Therapeutics in May 2022 for $2.20 per share in cash.
Also Read: FDA's AdComm Panel Favors Innoviva's Drug For Multidrug-Resistant Bacterial Infections.
Entasis was established in 2015 as a spin-off from AstraZeneca Plc AZN.
Innoviva anticipates that Xacduro will be available to patients later this year.
According to the World Health Organization, Acinetobacter species top the list of critical bacterial pathogens that pose the greatest threat to human health, the FDA wrote. A. baumannii can become highly resistant to multiple antibacterial drugs, with limited treatment options.
In a Phase 3 ATTACK trial, the drug proved non-inferior to the last-resort antibiotic colistin in 28-day all-cause mortality, demonstrating a significant difference in clinical cure rates.
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