Mumbai-based pharmaceutical company Wockhardt has achieved a historic milestone by submitting the first New Drug Application (NDA) to the US Food and Drug Administration for a drug fully discovered and developed by an Indian pharmaceutical company. The company announced the submission of its novel antibacterial agent Zidebactam-Cefepime injection (WCK 5222, ZAYNICH) for the treatment of complicated urinary tract infections.
Addressing Critical Unmet Medical Need
The NDA seeks approval for treating complicated urinary tract infections (cUTI), including pyelonephritis, with or without concurrent bacteremia caused by Gram-negative bacteria, including multidrug-resistant (MDR) strains. This represents a significant therapeutic advancement in addressing the escalating global crisis of antimicrobial resistance.
In the US and EU, more than 8 million cases of cUTI are reported every year, reflecting the substantial global burden of Gram-negative infections. Gram-negative infections have become increasingly difficult to treat due to widespread resistance to multiple classes of antibiotics.
Novel Mechanism of Action
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 recently approved ones.
Clinical and non-clinical studies have demonstrated the drug's potent activity against multi-drug resistant (MDR) and extreme drug resistant (XDR) Gram-negative pathogens, including those harboring NDM carbapenemases and PBP mutations. The combination has the potential to treat a broad range of infections caused by MDR or XDR pathogens including Enterobacterales, Pseudomonas aeruginosa, and A. baumannii.
Comprehensive Clinical Development Program
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 robust clinical development package includes nine Phase I studies conducted in the US and China, a Phase II study conducted in India, and the multinational Phase III trial evaluating efficacy in cUTI, including pyelonephritis.
A Phase II study has demonstrated the drug's efficacy against diverse carbapenem-resistant infections, highlighting its potential to overcome clinically important resistance mechanisms in Gram-negative pathogens including tough-to-treat Pseudomonas, Stenotrophomonas, Acinetobacter, and Klebsiella.
Regulatory Recognition and Scientific Validation
Zidebactam-cefepime has been granted qualified infectious disease product (QIDP) and Fast Track Designation by the US FDA, recognizing its potential to address serious unmet medical needs. The drug's spectrum of activity has been documented through more than 100 publications and presentations, with the majority from US and EU-based independent experts and organizations.
Market Impact
Following the announcement, Wockhardt shares were trading 1.33 percent down at Rs 1,493.90 apiece, reflecting typical market response to regulatory milestone announcements in the pharmaceutical sector.
