Drug-resistant Acinetobacter baumannii is a significant global health threat, and the World Health Organization (WHO) has classified it as a top-priority pathogen requiring new antibiotics. Approximately 300,000 cases of Acinetobacter infections occur annually in China, with approximately 74% being carbapenem-resistant.
Zai Lab Limited and Innoviva Specialty Therapeutics have announced the approval of XACDURO® (sulbactam-durlobactam) by China’s National Medical Products Administration (NMPA) to treat hospital-acquired and ventilator-associated bacterial pneumonia caused by Acinetobacter baumannii-calcoaceticus complex in patients aged 18 years and older.
The NMPA approval was based on positive results from the Phase 3 ATTACK trial, which demonstrated XACDURO’s non-inferiority to colistin for all-cause mortality in patients with carbapenem-resistant Acinetobacter infections. Additionally, XACDURO showed a statistically significant improvement in clinical cure rates.
XACDURO has been well-tolerated and has had a favorable safety profile throughout clinical trials. Zai Lab participated in the global ATTACK study and enrolled patients in China, confirming the positive findings of the global study regarding mortality and clinical response improvement.
This approval marks a significant step in addressing the unmet medical need for new antibiotics to combat drug-resistant Acinetobacter infections. It is the first FDA-approved pathogen-targeted therapy for hospital-acquired and ventilator-associated pneumonia caused by Acinetobacter baumannii-calcoaceticus complex.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
