CHMP recommends Zerbaxa (ceftolozane / tazobactam)for treatment of cIAI ,cUTI and acute pyelonephritis. Merck Inc.
Zerbaxa (ceftolozane / tazobactam) from Merck Inc., received a positive opinion from the CHMP for the treatment of complicated intra-abdominal infections (cIAI), acute pyelonephritis and complicated urinary tract infections (cUTI).
Comment: Zerbaxa met the cUTI study’s primary endpoint of statistical non-inferiority compared to levofloxacin (10% non-inferiority margin). The primary endpoint was a composite of microbiological eradication and clinical cure rate (composite cure rate) at 5-9 days after the end of therapy (the test of cure visit). In the second study, treatment with Zerbaxa plus metronidazole was shown to be effective in patients with cIAI, including those infections caused by certain resistant pathogens, such as extended-spectrum beta-lactamase (ESBL) producing Enterobacteriacae. Results of the secondary analyses for the studies were consistent with and supportive of the primary outcomes.
Comment:Zerbaxa was FDA approved for treatment of cUTI and cIA Infections in December 2014.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins