A Phase 3 clinical trial, ASPECT-NP, evaluating Merck's (NYSE:MRK) combo antibiotic ZERBAXA (ceftolozane and tazobactam) in adult patients with ventilated nosocomial (hospital acquired) pneumonia showed it to be non-inferior (no worse than) to meropenem. The results are being presented today at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Amsterdam.
Based on these data, the company has filed supplemental marketing applications in the U.S. and Europe seeking approval for this new indication.
The FDA's action date is June 3.
The FDA first approved ZERBAXA in December 2014 for complicated intra-abdominal/urinary tract infections.
Subscribe for full text news in your inbox