Zai Lab and Innoviva Specialty Therapeutics have received approval from China’s National Medical Products Administration (NMPA) for Xacduro (sulbactam-durlobactam) to treat certain pneumonia patients in China.
NMPA has approved Zai Lab’s new drug application (NDA) for Xacduro to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older.
Xacduro is an intravenous drug made from a combination of sulbactam, a β-lactam antibiotic, and a β-lactamase inhibitor called durlobactam.
It was developed by Entasis Therapeutics, an affiliate of Innoviva Specialty Therapeutics. In May 2023, Innoviva Specialty Therapeutics secured the US Food and Drug Administration (FDA) approval for Xacduro for the treatment of HABP/VABP.
Zai Lab holds an exclusive licence to develop and commercialise the drug in Greater China, Korea, Thailand, Vietnam, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Australia, Singapore, New Zealand, and Japan.
Innoviva Specialty Therapeutics president Matt Ronsheim said: “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 US.”
The approval was based on the positive results from the global, Phase 3 registrational ATTACK trial. It is for HABP/VABP resulting from susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.
The ATTACK trial assessed the safety and efficacy of Xacduro against colistin in patients with infections caused by Acinetobacter baumannii (A. baumannii).
According to the results, Xacduro proved its statistical non-inferiority to colistin regarding the primary endpoint of 28-day all-cause mortality.
It also demonstrated a statistically significant enhancement in clinical cure rates.
Additionally, the intravenous drug demonstrated good tolerance and maintained a positive safety record throughout the clinical programme.
The data from the Chinese patient group validated the results of the broader global study regarding mortality reduction and clinical response improvement.
Zai Lab autoimmune and infectious diseases neuroscience global development president and head 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.”
