Wockhardt Limited announced that the U.S. Food and Drug Administration (FDA) has approved ZAYNICH™ (cefepimeand zidebactam), a novel intravenous antibiotic for treating adults with complicated urinary tract infections (cUTI), including pyelonephritis.
This milestone marks a historic achievement as ZAYNICH™ is the first New Chemical Entity (NCE) fully developed and commercialized by an Indian pharmaceutical company to receive FDA approval. The drug previously secured Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA to address the escalating crisis of antimicrobial resistance.
The approval is supported by robust data from the Phase 3 ENHANCE-1 clinical trial. In the study, ZAYNICH™ demonstrated a significantly higher composite clinical cure and microbiological response rate of 89.0% compared to 68.4% for meropenem, while proving to be generally well tolerated.
Unlike traditional beta-lactam combinations, ZAYNICH™ utilizes a unique, multi-target synergy that simultaneously attacks multiple penicillin-binding proteins. This mechanism provides potent bactericidal activity against the most challenging drug-resistant Gram-negative bacteria, offering a critical new tool for healthcare systems burdened by over 600,000 annual cUTI hospitalizations in the U.S. alone.
“This approval is a significant realization of our mission to provide patients with novel antibiotics that help to address one of the most urgent global health threats,” said Dr. Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
