A Phase 3 clinical study evaluating the investigational antibiotic Zerbaxa (ceftolozane and tazobactam) met its primary endpoints in the treatment of ventilated hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). The drug demonstrated non-inferiority to meropenem in 28-day all-cause mortality and in clinical cure rate.
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Based on these results, supplemental new drug applications will be submitted to the US FDA and European Medicines Agency (EMA) seeking regulatory approval of Zerbaxa for HAP/VAP. Full results from the study will be presented at a future scientific conference.
Zerbaxa is currently indicated in the US for adult patients for the treatment of complicated urinary tract infections, including pyelonephritis, caused by certain Gram-negative microorganisms, and is indicated, in combination with metronidazole, in adult patients for the treatment of complicated intra-abdominal infections caused by certain Gram-negative and Gram-positive microorganisms.