Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

For use in treatment of complicated urinary tract infections

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 lactam enhancer and 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.

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