Zai Lab and Innoviva Specialty Therapeutics have announced the approval of China’s National Medical Products Administration (NMPA) for Zai’s new drug application (NDA) submitted for XACDURO (sulbactam-durlobactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).
The NDA approval will facilitate the use of XACDURO for HABP/VABP caused by acinetobacter baumannii-calcoaceticus complex in patients aged 18 years and above.
The NMPA’s decision was based on the positive outcomes of the ATTACK trial.
This international Phase III registrational study assessed the safety and efficacy of XACDURO compared to colistin in patients with infections due to A baumannii.
XACDURO was demonstrated to be non-inferior to colistin in terms of 28-day all-cause mortality and a significant improvement in clinical cure rates among patients with carbapenem-resistant acinetobacter infections.
Treatment with XACDURO was also found to be well-tolerated with a favourable safety profile across the clinical programme.
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Zai Lab’s contribution to the global ATTACK study included enrolling Chinese patients.
In May 2023 the US Food and Drug Administration (FDA) approved XACDURO to treat HABP/VABP caused by susceptible isolates of acinetobacter baumannii-calcoaceticus complex.
Developed by Innoviva affiliate Entasis Therapeutics, the intravenous drug XACDURO is a combination of sulbactam, a β-lactam antibiotic, and durlobactam, a β-lactamase inhibitor (BLI).
Zai Lab holds the exclusive licence for the development and commercialisation of XACDURO in countries including Australia, Greater China, Japan, Korea, New Zealand and Vietnam.
Zai Lab global development, neuroscience, autoimmune and infectious diseases president and head Dr Harald Reinhart said: “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.
“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 latest development comes after the NMPA approved Zai Lab’s NDA for Augtyro (repotrectinib) in the treatment of adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
