Wockhardt today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (US FDA) for its novel antibacterial agent Zidebactam-Cefepime injection (WCK 5222, brand name ZAYNICH™). The application seeks approval for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant (MDR) strains.
The NDA submission marks the first-ever US FDA application for a drug fully discovered and developed by an Indian pharmaceutical company, highlighting a significant milestone for Indian innovation. Zidebactam-Cefepime, a first-in-class ß-lactam enhancer and ß-lactam combination, introduces a novel mechanism of action to tackle infections resistant to currently approved antibiotics. Clinical and non-clinical studies have shown potent activity against MDR and extreme drug-resistant (XDR) Gram-negative pathogens, including those with NDM carbapenemases and PBP mutations.
The submission follows successful completion of a pivotal Phase III global trial (ENHANCE 1) conducted across 64 sites in India, USA, Bulgaria, Estonia, Lithuania, Poland, Slovakia, Mexico, and China, supported by a comprehensive clinical development program including nine Phase I studies and a Phase II study.
Zidebactam-Cefepime has received Qualified Infectious Disease Product (QIDP) and Fast Track Designation from the US FDA. The drug shows promise in treating a broad spectrum of infections caused by MDR and XDR pathogens such as Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter baumannii, addressing the growing global challenge of antimicrobial resistance.