NMPA Approves Xacduro for HABP/VABP Caused by Acinetobacter Baumannii-Calcoaceticus Complex

NMPA Approves Xacduro for HABP/VABP Caused by Acinetobacter Baumannii-Calcoaceticus Complex

By, Admin 22 May 2024

China NMPA approves Zai Lab & Innoviva Specialty’s Xacduro for HABP/VABP caused by Acinetobacter baumannii-calcoaceticus complex

Overview

Zai Lab Limited, an innovative, research-based, commercial-stage biopharmaceutical company, and Innoviva Specialty Therapeutics announced that 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.

Xacduro Approval

  • “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.”

ATTACK Trial Outcomes

  • 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 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 favourable 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.

FDA Approval for Xacduro

In May 2023, Innoviva Specialty Therapeutics announced that the US 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.

From Innoviva Specialty Therapeutics

  • “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 US.”

Xacduro

  • Xacduro (sulbactam-durlobactam) is an intravenous drug developed by Entasis Therapeutics Inc., an affiliate of Innoviva Specialty Therapeutics, which is a combination of sulbactam, a ß-lactam antibiotic, and durlobactam, a ß-lactamase inhibitor, or BLI. 
  • Xacduro has been approved in the United States and mainland China for the treatment of adult patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. 
  • Zai Lab has an exclusive license to develop and commercialize Xacduro in Greater China (mainland China, Hong Kong, Taiwan and Macau, collectively), Korea, Vietnam, Thailand, Cambodia, Laos, Malaysia, Indonesia, the Philippines, Singapore, Australia, New Zealand and Japan.

All Gram-Negative Pathogens

  • Members of the Acinetobacter baumannii-calcoaceticus complex (Acinetobacter) are Gram-negative, opportunistic human pathogens that predominantly infect critically ill patients and often result in severe pneumonia and bloodstream infections. 
  • They can also infect other body sites, such as the urinary tract and the skin. 
  • Acinetobacter is considered a global threat in the healthcare setting due in part to its ability to acquire multidrug resistance. 
  • Acinetobacter is resistant to penicillins and has also acquired resistance genes for almost all antibiotics used to treat Gram-negative bacteria, including fluoroquinolones, aminoglycosides, cephalosporins, and carbapenems.

Carbapenem-Resistant Micro-Organisms: An urgent Threat

  • The Centers for Disease Control and Prevention (CDC) has identified carbapenem-resistant micro-organisms as an urgent threat. 
  • Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 2019. 
  • Carbapenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO).

Prevalence in US

  • In the US, there are an estimated 40,000 to 80,000 cases of Acinetobacter each year, and about 40 percent of those are carbapenem-resistant Acinetobacter. 
  • Globally, there are about a million cases each year of Acinetobacter, and about two-thirds of those are carbapenem-resistant Acinetobacter baumannii. 
  • More than 300,000 global deaths annually are associated with carbapenem-resistant Acinetobacter.

Based on the 2022 Annual Report of CARSS (China Antimicrobial Resistance Surveillance System), approximately 300,000 Acinetobacter infections were reported in mainland China. According to the most recent CHINET report, resistance of Acinetobacter baumannii to the carbapenem class of antibiotics has risen to approximately 74% in China. Acinetobacter is also the most common pathogen that leads to hospital-acquired pneumonia and ventilator-associated pneumonia in China. With commercially available therapy, the mortality rate is estimated to be 38% in China and 43% in Eastern Asia.

Zai Lab

  • Zai Lab is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. 
  • The company focused on discovering, developing and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, autoimmune disorders, infectious disease and neuroscience.

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