USFDA grants fast track designation to Wockhardt novel antibiotic WCK 6777
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Mumbai: Wockhardt has announced that its unique once-a-day, β-lactam enhancer based MDR-active antibiotic, WCK 6777 (Ertapenem/Zidebactam) has successfully completed a Phase I study conducted by the Division of Microbiology and Infectious Diseases (DMID) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in US.
Recognizing the therapeutic potential of WCK 6777 for infections caused by MDR Gram negative pathogens, DMID of NIH had selected this drug for Phase I studies. Zidebactam has already demonstrated promising safety profile in Phase I and on-going Phase II & III studies in combination with Cefepime (WCK 5222).
Additionally, recognizing its potential to meet significant unmet medical needs, the US FDA has recently granted Fast Track designation to WCK 6777 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and complicated intra-abdominal infections (cIAI).
WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient- parenteral antimicrobial therapy (OPAT) in ambulatory settings. WCK 6777 is active against entire range of meropenem-resistant Gram negative pathogens generally encountered in community as well as hospital urinary tract infections (UTI) and intra-abdominal infections (IAI). Such a therapeutic option is expected to cut hospital admissions, facilitate early patient discharge and thus offer patient-centred care for MDR infections.
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