Zai Lab and Innoviva Specialty Therapeutics secure approval for XACDURO for hospital-acquired and ventilator-associated pneumonia in China

China’s National Medical Products Administration (NMPA) has approved Zai Lab’s New Drug Application (NDA) for XACDURO® (sulbactam-durlobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in patients 18 years of age and older. The World Health Organization considers Acinetobacter a top-priority pathogen worldwide that needs novel antibiotics.

“The NMPA approval of XACDURO demonstrates Zai Lab’s commitment to developing and delivering innovative therapies that address high unmet medical needs for patients in China and around the world,” said Dr. Harald Reinhart, President and Head of Global Development, Neuroscience, Autoimmune & Infectious Diseases, Zai Lab. “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.”

The NMPA approval of XACDURO in China is based on positive results from the ATTACK trial, 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 study, 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. 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 Specialty Therapeutics announced that the U.S. Food and Drug Administration (FDA) approved XACDURO for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex – the first such FDA-approved pathogen-targeted therapy.

“Six years ago, our two companies shared the vision of creating an innovative antibiotic therapy that could effectively address the global rise of drug-resistant Acinetobacter-related infections,” said Matt Ronsheim, PhD, President of Innoviva Specialty Therapeutics. “This approval is a testament to our strong and successful partnership with Zai Lab. Their invaluable collaboration during the Phase 3 trials provided the crucial data needed to move XACDURO through the regulatory process in China, just one year after it was approved in the U.S.”

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