Wockhardt has submitted a New Drug Application (NDA) to the U.S. FDA for its novel antibacterial agent, Zidebactam-Cefepime (WCK 5222), also known as ZAYNICHâ„¢. The application seeks approval for treating complicated urinary tract infections (cUTI), including those caused by multidrug-resistant Gram-negative bacteria. This marks the first NDA submission by an Indian company for a fully discovered and developed drug. Zidebactam-Cefepime has received both QIDP and Fast Track designations from the FDA.
FDA Submission Highlights
Wockhardt announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zidebactam-Cefepime injection (WCK 5222, ZAYNICHâ„¢). This antibiotic seeks approval for complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia, caused by Gram-negative bacteria. The submission highlights a significant milestone as the first NDA submission to the U.S. FDA for a drug fully discovered and developed by an Indian pharmaceutical company.
About Zidebactam-Cefepime
Zidebactam-Cefepime represents a first-in-class β-lactam enhancer and β-lactam combination aimed at addressing antimicrobial resistance (AMR). It targets difficult-to-treat infections unresponsive to existing antibiotics. Clinical and non-clinical studies demonstrate its activity against multi-drug resistant (MDR) and extreme drug-resistant (XDR) Gram-negative pathogens, including those with NDM carbapenemases and PBP mutations.
Clinical Trial Results
The NDA submission is supported by the successful completion of the Phase III global clinical trial (ENHANCE 1), conducted across 64 sites in multiple countries. This program includes nine Phase I studies conducted in the U.S. and China, a Phase II study in India, and a multinational Phase III trial evaluating efficacy in cUTI.
Regulatory Status
Zidebactam-Cefepime has been granted qualified infectious disease product (QIDP) and Fast Track Designation by the US FDA. This designation helps accelerate the drug’s development and review process, reflecting its potential to address critical unmet needs in treating severe infections.
Target Infections
The drug is designed to combat infections caused by MDR or XDR pathogens, including Enterobacterales, Pseudomonas aeruginosa, and A. baumannii. It has demonstrated a broad spectrum of activity against pathogens, including those that are tough-to-treat.
Source: BSE
