Global healthcare major Wockhardt has cleared a major regulatory hurdle as the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) gave a favourable recommendation for its novel antibiotic, Zaynich (Zidebactam/Cefepime), for the treatment of Gram-negative infections.
The move paves the way for final approval from the Drugs Controller General of India (DCGI).
Developed over 15 years by a team of more than 150 scientists across 10 disciplines, Zaynich employs a novel β-lactam enhancer-based mechanism, offering potentially unprecedented coverage of multidrug- and extensively drug-resistant (MDR/XDR) Gram-negative pathogens in India.
The recommendation follows an exhaustive review of the product dossier, including nine Phase 1 studies, a multi-indication Phase 2 trial in meropenem-resistant infections, a global Phase 3 study in complicated urinary tract infections and acute pyelonephritis, and data from 85 compassionate-use cases.
In its global Phase 3 study involving 530 patients across 64 sites in the United States, Europe, Latin America, China, and India, Zaynich demonstrated superiority over meropenem in combined clinical and microbiological cure, highlighting the impact of its unique mechanism of action.
Earlier real-world studies in India showed over 97% clinical efficacy against meropenem-resistant infections, including hospital-acquired and ventilator-associated pneumonia, bloodstream infections, complicated intra-abdominal infections, and cUTI.
“Zaynich has also demonstrated strong efficacy in 85 XDR Gram-negative infection cases treated under compassionate use in India, US, Malaysia and France where no safe and efficacious alternatives were available,” Wockhardt noted, emphasizing the drug’s potential to address a critical global unmet need.
The Clinical and Laboratory Standards Institute (CLSI) has granted Zidebactam/Cefepime an investigational susceptible breakpoint of 64 mg/L, signalling its potential to comprehensively cover clinically important XDR Gram-negative pathogens in critically ill patients.
Wockhardt has already submitted a New Drug Application (NDA) in the United States and a Marketing Authorisation Application (MAA) in the European Union, both in advanced stages of review, positioning Zaynich for a global rollout.
With this CDSCO nod, Wockhardt edges closer to delivering one of the most comprehensively evaluated antibiotics in recent years, backed by over 100 national and international publications and presentations, most from independent experts.
