Wockhardt’s novel antibiotic, Zaynich® (Zidebactam/Cefepime), has received a favourable recommendation from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for marketing permission. This positive opinion is a significant step towards final approval by the Drugs Controller General of India (DCGI).
The recommendation was granted following a thorough review of the product dossier, which included non-clinical data, nine Phase 1 studies, a multi-indication Phase 2 study on meropenem-resistant infections, a global Phase 3 study on complicated urinary tract infections and acute pyelonephritis (cUTI/AP), and data from 85 compassionate-use cases.
Developed over 15 years by a team of over 150 scientists across ten disciplines, Zaynich® employs a novel β-lactam enhancer-based mechanism. This innovative approach offers potentially unprecedented coverage of multi-drug resistant (MDR) and extensively drug-resistant (XDR) Gram-negative pathogens prevalent in India. It is one of the most comprehensively evaluated antibiotics globally in recent years, with over 100 national and international publications and presentations, primarily from independent experts.
The clinical programme for Zaynich® includes nine Phase 1 studies conducted in the United States and China involving nearly 300 subjects. This was followed by a global Phase 3 study involving 530 patients across 64 sites in the United States, Europe, Latin America, China, and India, as well as a Phase 2 study on meropenem-resistant infections.
In the Phase 3 study, Zidebactam/Cefepime demonstrated superiority over meropenem in combined clinical and microbiological cure rates, highlighting the impact of its novel mechanism of action. Earlier studies showed over 97% clinical efficacy in real-world settings for meropenem-resistant infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and cUTI, conducted across 15 leading tertiary care hospitals in India.
Zaynich® also showed strong efficacy in 85 XDR Gram-negative infection cases treated under compassionate use in India, the US, Malaysia, and France, where no safe and efficacious alternatives were available. This underscores the global unmet medical need in treating resistant Gram-negative infections and the potential of Zaynich® to address it.
The Clinical and Laboratory Standards Institute (CLSI) has granted Zidebactam/Cefepime an investigational susceptible breakpoint of 64 mg/L, indicating its potential to comprehensively cover clinically important XDR Gram-negative pathogens in critically ill patients.
A New Drug Application (NDA) in the United States and a Marketing Authorisation Application (MAA) in the European Union for Zidebactam/Cefepime have already been submitted and are currently in the advanced stages of review.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).