Pfizer’s Zavicefta Approved by China’s NMPA for Severe Infections in All Ages

Pfizer's Zavicefta Approved by China's NMPA for Severe Infections in All Ages

US-based pharmaceutical giant Pfizer (NYSE: PFE) announced that it has received market approval from China’s National Medical Products Administration (NMPA) for its avibactam sodium + ceftazidime product, branded as Zavicefta. The drug is indicated for the treatment of complex intra-abdominal infections (cIAI) caused by gram-negative bacteria, hospital-acquired pneumonia (HAP), and ventilator-associated pneumonia (VAP). It is also approved for infections with limited treatment options in children of all ages, including newborns.

Drug Overview and Previous Approvals
Zavicefta was first approved in China in May 2019 for treating cIAI, HAP, and ventilator-associated pneumonia, as well as infections caused by specific gram-negative bacteria such as Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Proteus mirabilis, and Pseudomonas aeruginosa in adult patients with limited therapeutic options. In October 2022, the drug received further approval in China for treating children aged three months and older with cIAI.

Acquisition and Development History
Zavicefta was co-developed by AstraZeneca and Allergan’s unit Forest Laboratories. Pfizer acquired the drug through a small-molecule antibiotics business deal with AstraZeneca in December 2016, obtaining exclusive development, marketing, and commercialization rights globally, excluding the US and Canada.-Fineline Info & Tech