Zerbaxa Receives New Indication
June 3, 2019 – The U.S. FDA has approved a new indication for Zerbaxa® (ceftolozane and tazobactam), manufactured by Merck. The drug is now indicated to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by susceptible Gram-negative bacteria in patients who are at least 18 years of age.
The U.S. Centers for Disease Control and Prevention (CDC) report that HABP and VABP are the second most common forms of hospital-acquired infection in the country. Mortality rates can be high—up to 39% in ventilated patients who have hospital-acquired bacterial pneumonia, according to the Foundation for the National Institutes of Health Biomarkers Consortium. Pseudomonas aeruginosa, an increasingly difficult-to-treat bacterium, is the most common microorganism responsible for HABP and VABP.
In a clinical study, Zerbaxa was found to have similar mortality and cure rates when compared to a current standard of treatment, meropenem. Patients treated with Zerbaxa had a mortality rate of 24%, compared to 25.3% with meropenem, and a cure rate of 54.4% compared to 53.3% with meropenem. Ventilated patients treated with Zerbaxa had an improvement in mortality rate (24.2%) versus those treated with meropenem (37%).
Recommended dosing under the new indication is 3g administered every eight hours by intravenous (IV) infusion for 8-14 days. Zerbaxa should only be used to treat or prevent HABP/VABP that is proven or strongly suspected to be caused by susceptible bacteria. The bacteria susceptible to Zerbaxa are Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens.
Originally FDA-approved in 2014, Zerbaxa is also indicated to treat complicated urinary tract infections (cUTI), including pyelonephritis, and for use in combination with metronidazole to treat complicated intra-abdominal Infections (cIAI).