US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its antibiotic Zerbaxa (ceftolozane, tazobactam). The fixed-dose combination antibiotic medication is approved to treat a range of complex infections in both adult and pediatric patients.
Approved Indications
Zerbaxa is approved for the treatment of complex intra-abdominal infections (cIAI) caused by sensitive gram-negative and gram-positive microorganisms, in combination with metronidazole. It is also approved for complex urinary tract infections (cUTIs), including pyelonephritis, caused by sensitive gram-negative microorganisms. Additionally, it is approved for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VAPP) in adult patients (18 years and older) caused by sensitive gram-negative microorganisms.
Context of Approval
Pseudomonas aeruginosa (PA) and Escherichia coli are common gram-negative bacteria in hospital-acquired infections in China. The proportion of drug-resistant Pseudomonas aeruginosa (MDRPA) in various types of infection patients in China is high, with 57.3% being multidrug-resistant. The mortality rate of lower respiratory tract infections caused by MDRPA is high, and treatment is difficult. The production of extended-spectrum β-lactase-producing Escherichia coli (ESBL-E) is also a significant clinical issue, with a detection rate of up to 62% in patients with urinary tract infections.-Fineline Info & Tech
