US-based pharmaceutical giant Pfizer (NYSE: PFE) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its avibactam sodium + ceftazidime product, marketed under the brand name Zavicefta, in China. The indication is for children three months and older with complex intra-abdominal infection (cIAI).
Previous Approvals and Indications
The drug was first approved in China in May 2019 to treat complex intra-abdominal infection (cIAI), hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia, as well as infections caused by Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Proteus mirabilis, and Pseudomonas aeruginosa in adult patients with limited therapeutic options. Zavicefta, co-developed by AstraZeneca and Allergan’s unit Forest Laboratories, was acquired by Pfizer in a small-molecule antibiotics business deal in December 2016. Pfizer obtained exclusive development, marketing, and commercialization rights to the drug globally, excluding the US and Canada. The drug is currently marketed in over 40 countries and regions.
Clinical Need and Zavicefta’s Mechanism
CIAI refers to infections that extend from the primary cavity organ to the abdominal cavity, leading to secondary or type III peritonitis, which can be combined with sepsis, septic shock, and multiple organ failure. The resistance of common Gram-negative pathogens in pediatric cIAI to carbapenem antibiotics is severe. The use of carbapenem antibiotics is one of the high-risk factors for carbapenem-resistant (CRE) colonization or infection in children, with the risk of death in 30 days for children with CRE infection nearly six times higher than that for those with carbapenem-sensitive (CSE) infection. Therefore, compared with adults, pediatric cIAI treatment must consider multiple factors, including the infection risk of possible pathogens, drug-resistant bacteria, sensitivity of pathogens to antibacterial drugs, and the liver and kidney functions of children.
Zavicefta, which can inhibit most β-lactamase and covers common Gram-negative pathogens and carbapenem-resistant bacteria, has been approved in the United States and the European Union to treat cIAI in children aged three months and above. Real-world studies and case reports have further confirmed that the drug can be used as a rescue treatment for children with intra-abdominal infections of CRE after liver transplantation. Guidelines by the Infectious Diseases Society of America (IDSA) in 2022 recommend the drug as one of the optimal treatments for infections caused by carbapenem-resistant Enterobacteriaceae (CRE) and refractory Pseudomonas aeruginosa (PA) in both adults and children.
Future Outlook
The approval of Zavicefta by the NMPA underscores Pfizer’s commitment to addressing the growing challenge of antibiotic resistance in pediatric infections. By expanding its indications to include pediatric cIAI, Zavicefta aims to provide a much-needed treatment option for children with severe infections.-Fineline Info & Tech
