China-based Everest Medicines Limited (HKG: 1952) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its antibiotic Xerava (eravacycline). The approval is for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in China, with plans to commercialize the product during the third quarter of 2023.
Understanding cIAI
Complicated intra-abdominal infections (cIAI) are infectious diseases caused by hospital or community-acquired infections that extend from hollow viscera to the peritoneal cavity, leading to conditions such as peritonitis or abscess. The disease encompasses various conditions, including abdominal abscess, gastric or intestinal perforation, peritonitis, appendicitis, cholecystitis, and diverticulitis. It is caused by different pathogens, including gram-negative, gram-positive, and anaerobic bacteria. In 2018, approximately 2.9 million people in China were affected by this disease.
Xerava’s Profile and Approvals
Xerava is a novel, fully synthetic, broad-spectrum, fluorocycline antibiotic of the tetracycline class. It has demonstrated broad in vitro activity against gram-negative and gram-positive pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Xerava is currently approved for the treatment of cIAI in the US, EU, UK, and Singapore, and is under marketing review in Taiwan. The drug was licensed from Tetraphase Pharmaceuticals, a wholly-owned subsidiary of La Jolla Pharmaceutical Company.-Fineline Info & Tech
