Mumbai: Wockhardt has 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,
ZAYNICH).
The NDA 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).
including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria including
multidrug-resistant (MDR).
In US and EU, more than 8 million cUTI cases are reported every year, reflecting
the global burden of Gram negative infections.
the global burden of Gram negative infections.
According to the release, amidst the escalating global crisis of antimicrobial resistance (AMR), Zidebactam-Cefepime represents a
first-in-class β-lactam enhancer and β-lactam combination, introducing a novel mechanism of action to
combat some of the most difficult-to-treat infections particularly those that remain unresponsive to approved
antibiotics, including those that are recently approved.
first-in-class β-lactam enhancer and β-lactam combination, introducing a novel mechanism of action to
combat some of the most difficult-to-treat infections particularly those that remain unresponsive to approved
antibiotics, including those that are recently approved.
Clinical and non-clinical studies have demonstrated
its potent activity against multi-drug resistant (MDR) and extreme drug resistant (XDR) Gram-negative
pathogens, including those harbouring NDM carbapenemases and PBP mutations. A Phase II study
undertaken has demonstrated its efficacy against diverse carbapenem-resistant infections.
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
(ENHANCE 1), conducted across 64 sites in India, USA, Bulgaria, Estonia, Lithuania, Poland, Slovakia,
Mexico, and China. The program is supported by a robust clinical development package, including nine
Phase I studies conducted in the U.S. and China, a Phase II study conducted in India and a multinational
Phase III trial evaluating efficacy in cUTI, including pyelonephritis.
its potent activity against multi-drug resistant (MDR) and extreme drug resistant (XDR) Gram-negative
pathogens, including those harbouring NDM carbapenemases and PBP mutations. A Phase II study
undertaken has demonstrated its efficacy against diverse carbapenem-resistant infections.
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
(ENHANCE 1), conducted across 64 sites in India, USA, Bulgaria, Estonia, Lithuania, Poland, Slovakia,
Mexico, and China. The program is supported by a robust clinical development package, including nine
Phase I studies conducted in the U.S. and China, a Phase II study conducted in India and a multinational
Phase III trial evaluating efficacy in cUTI, including pyelonephritis.
Zidebactam-cefepime has been granted qualified infectious disease product (QIDP) and Fast Track
Designation by US FDA.
Gram-negative infections have become increasingly difficult to treat due to wide spread resistance to multiple
classes of antibiotics. Zaynich has the potential to treat a broad range of infections caused by MDR or
XDR pathogens including Enterobacterales and Pseudomonas aeruginosa and A. baumannii.
Designation by US FDA.
Gram-negative infections have become increasingly difficult to treat due to wide spread resistance to multiple
classes of antibiotics. Zaynich has the potential to treat a broad range of infections caused by MDR or
XDR pathogens including Enterobacterales and Pseudomonas aeruginosa and A. baumannii.
Zaynich, combination of Zidebactam & Cefepime, is Wockhardt’s novel proprietary antibiotic, targeted
towards multi-drug resistant Gram-negative infections. Zaynich is a novel β-lactam enhancer mechanism
of action drug, which overcomes all the clinically important resistance mechanisms in Gram negative pathogens including tough-to-treat Pseudomonas, Stenotrophomonas, Acinetobacter and Klebsiella. Such
spectrum of activity of Zaynich has been documented through >100 publications/presentations, majority
from US and EU based independent experts/organizations.
towards multi-drug resistant Gram-negative infections. Zaynich is a novel β-lactam enhancer mechanism
of action drug, which overcomes all the clinically important resistance mechanisms in Gram negative pathogens including tough-to-treat Pseudomonas, Stenotrophomonas, Acinetobacter and Klebsiella. Such
spectrum of activity of Zaynich has been documented through >100 publications/presentations, majority
from US and EU based independent experts/organizations.
