Zai Lab Ltd. (ZLAB) and Innoviva Specialty Therapeutics announced Monday that China's National Medical Products Administration or NMPA has approved Zai Lab's New Drug Application for XACDURO (sulbactam-durlobactam) to treat hospital-acquired and ventilator-associated pneumonia caused by Acinetobacter baumannii-calcoaceticus complex in China.
XACDURO is an intravenous drug developed by Entasis Therapeutics Inc., an affiliate of Innoviva. Zai Lab has an exclusive license to develop and commercialize XACDURO in Greater China as well as certain other countries.
The World Health Organization considers Acinetobacter a top-priority pathogen worldwide that needs novel antibiotics.
The treatment with XACDURO is now approved for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia or HABP/VABP caused by susceptible isolates of A. baumannii-calcoaceticus complex in patients 18 years of age and older.
The NMPA approval of XACDURO in China is based on positive results from the ATTACK trial (NCT03894046), a global, Phase 3 registrational trial evaluating the safety and efficacy of XACDURO versus colistin in patients with infections caused by A. baumannii.
In the pivotal trial, XACDURO demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a statistically significant improvement in clinical cure rates.
The companies noted that XACDURO was well tolerated and exhibited a favorable safety profile across the clinical program. Zai Lab participated in the global ATTACK study by enrolling patients in China. The Chinese patient cohort data confirm the findings of the global study regarding mortality and clinical response improvement.
In May 2023, Innoviva announced that the U.S. Food and Drug Administration approved XACDURO to treat HABP/VABP caused by susceptible isolates of A. baumannii-calcoaceticus complex - the first such FDA-approved pathogen-targeted therapy.
Harald Reinhart, President and Head of Global Development, Neuroscience, Autoimmune & Infectious Diseases, Zai Lab, said, "The public threat of dangerous pan-resistant Acinetobacter infections requires urgent action, as treatment options are limited and mortality rates remain high. We believe XACDURO represents a major step forward in an area of significant patient need."
XACDURO has been approved in the U. S. and mainland China for the treatment of adult patients with HABP/VAB), caused by susceptible isolates of A. baumannii-calcoaceticus complex.
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