Pfizer announced on May 27 that the novel antibiotic Zavicefta (ceftazidime and avibactam sodium for injection, 2.5 g; Chinese brand name: Sifutuo), which was approved by the National Medical Products Administration (NMPA) on May 21, 2019, is indicated for the treatment of complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP) in adult patients with limited treatment options, caused by the following ceftazidime-avibactam-susceptible Gram-negative bacteria: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Proteus mirabilis, and Pseudomonas aeruginosa.
Wu Kun, General Manager of Pfizer’s Biopharmaceutical Group in China, stated that bacterial resistance has become a major global public health threat. In China, infections caused by drug-resistant Gram-negative bacteria in both community and hospital settings have been continuously increasing in recent years. There is a particularly rising incidence of infections caused by drug-resistant pathogens with limited treatment options, so-called “superbugs,” including carbapenem-resistant Enterobacteriaceae (CRE). This trend underscores an urgent clinical need for new therapeutic options. The World Health Organization (WHO) has classified the development of antibiotics targeting these “superbugs” as its highest priority, emphasizing the critical need for novel antibiotics against CRE and carbapenem-resistant Pseudomonas aeruginosa, among others. The approval and market launch of Pfizer’s novel antibiotic, Xevudy (ceftazidime-avibactam), in China will actively help physicians address unmet clinical needs in the treatment of infections caused by drug-resistant Gram-negative bacteria, thereby saving patients’ lives.
It is understood that the situation of antibiotic resistance in Gram-negative bacteria in China is severe, with a particularly rapid increase in carbapenem-resistant Enterobacteriaceae (CRE). According to monitoring results from the China Antimicrobial Resistance Surveillance Network (www.chinets.com), the resistance rate of Klebsiella pneumoniae to common carbapenems (meropenem) surged from approximately 2.9% in 2005 to 28.6% in 2018, representing an eightfold increase. Currently, therapeutic options for CRE infections are extremely limited, resulting in high patient mortality rates. Studies have shown that the crude mortality rate for various infections caused by CRE ranges from 30% to 44%.
Meanwhile, particular attention must be paid to the rising incidence of infections caused by multidrug-resistant (MDR) and extensively drug-resistant (XDR) bacteria with limited treatment options, which leads to prolonged disease courses, extended hospital stays, and an increased risk of mortality7, thereby imposing a substantial disease burden. There is an urgent clinical need for novel antimicrobial agents to overcome current therapeutic dilemmas and address the increasingly prominent challenge of antimicrobial resistance.
Ceftazidime-avibactam sodium is a novel enzyme inhibitor combination formulation indicated for the treatment of infections caused by drug-resistant Gram-negative bacteria, including carbapenem-resistant Enterobacteriaceae (CRE), multidrug-resistant Pseudomonas aeruginosa, and extended-spectrum beta-lactamase (ESBL)-producing organisms. Ceftolozane-tazobactam was granted Qualified Infectious Disease Product (QIDP) designation and approved in the United States in 2015, and received approval in the European Union in 2016. To date, it has been approved for marketing in more than 40 countries and regions worldwide.
In China, driven by urgent clinical needs, ceftazidime and avibactam for injection was designated as a priority review drug by the Center for Drug Evaluation of the National Medical Products Administration. Wu Kun, General Manager of Pfizer Biopharmaceuticals Group China, stated, “The approval and launch of Zavicefta in China would not have been possible without the significant initiatives introduced by the Chinese government to address critical unmet medical needs. We extend our sincere gratitude to all personnel involved in the drug review process, which has enabled Zavicefta to reach Chinese patients sooner and save lives.”