Wockhardt today announced the submission of 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). In US and EU, more than 8 Million cUTI cases are reported every year, reflecting the global burden of Gram negative infections.

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company, a momentous achievement for Indian innovation.

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. 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.

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.