Zai Lab Ltd. (ZLAB) and Innoviva Specialty Therapeutics announced on Monday that China's National Medical Products Administration (NMPA) has granted approval to Zai Lab's New Drug Application for XACDURO (sulbactam-durlobactam), intended to treat hospital-acquired and ventilator-associated pneumonia caused by the Acinetobacter baumannii-calcoaceticus complex.
XACDURO, an intravenous drug developed by Entasis Therapeutics Inc.—an affiliate of Innoviva—is now exclusively licensed to Zai Lab for development and commercialization in Greater China and select other countries. The World Health Organization has classified Acinetobacter as a top-priority pathogen in need of novel antibiotic solutions.
The recent approval allows XACDURO to be used in the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 and older, specifically for those with infections caused by susceptible strains of the A. baumannii-calcoaceticus complex.
The NMPA's decision was based on the positive outcomes from the global Phase 3 ATTACK trial (NCT03894046), which assessed the safety and efficacy of XACDURO in comparison to colistin in patients with A. baumannii infections. The pivotal trial demonstrated that XACDURO achieved statistical non-inferiority to colistin regarding the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections. Furthermore, XACDURO showed a statistically significant advantage in clinical cure rates.
The companies highlighted that XACDURO was well-tolerated, showcasing a favorable safety profile throughout the clinical program. Zai Lab participated by enrolling patients in China, with data from the Chinese cohort mirroring the global findings on mortality and clinical response improvements.
In May 2023, Innoviva announced FDA approval for XACDURO in the U.S. to manage HABP/VABP due to susceptible A. baumannii-calcoaceticus complex—marking the FDA's first approval for such targeted therapy.
Commenting on the development, Harald Reinhart, President and Head of Global Development for Neuroscience, Autoimmune, & Infectious Diseases at Zai Lab, stated, "The public threat posed by dangerous pan-resistant Acinetobacter infections necessitates urgent action, given the limited treatment options and high mortality rates. We believe XACDURO represents a significant advancement in addressing a crucial patient need."
XACDURO is now approved both in the U.S. and mainland China for treating adult patients with HABP/VABP resulting from susceptible isolates of the A. baumannii-calcoaceticus complex.
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