Wockhardt’s Zaynich® Receives Favourable Recommendation for Gram-Negative Infection Treatment

Wockhardt’s Zaynich® Receives Favourable Recommendation for Gram-Negative Infection Treatment​

Wockhardt Limited announced that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has granted a favourable recommendation for marketing permission of its novel antibiotic, Zaynich® (Zidebactam/Cefepime), for the treatment of Gram-negative infections. This recommendation paves the way for final approval by the Drugs Controller General of India (DCGI).

The recommendation follows a comprehensive review of the product dossier, which includes non-clinical data, nine Phase 1 studies, a multi-indication Phase 2 study in meropenem-resistant infections, a global Phase 3 study in complicated urinary tract infections and acute pyelonephritis (cUTI/AP), and data from 85 compassionate-use cases.

Developed over 15 years by a team of more than 150 scientists across 10 disciplines, Zaynich® features a novel β-lactam enhancer-based mechanism, designed to address MDR/XDR Gram-negative pathogens prevalent in India. It has been the subject of over 100 national and international publications and presentations, primarily from independent experts.

The Zaynich® clinical program included nine Phase 1 studies in the United States and China, involving nearly 300 subjects, a global Phase 3 study in 530 patients across 64 sites in the United States, Europe, Latin America, China, and India, and a Phase 2 study in meropenem-resistant infections.

In the Phase 3 study, Zidebactam/Cefepime demonstrated superiority over meropenem in combined clinical and microbiological cure. Earlier studies showed over 97% clinical efficacy in a real-world study of meropenem-resistant infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and cUTI.

Zaynich® also demonstrated strong efficacy in 85 XDR Gram-negative infection cases treated under compassionate use in India, the US, Malaysia and France, where safe and efficacious alternatives were unavailable.

The Clinical and Laboratory Standards Institute (CLSI) has granted Zidebactam/Cefepime an investigational susceptible breakpoint of 64 mg/L.

New Drug Application (NDA) and Marketing Authorisation Application (MAA) submissions for Zidebactam/Cefepime in the United States and European Union are currently in advanced review stages.

Wockhardt has focused its drug discovery efforts for 25 years in the area of discovering novel medicines for multi-drug resistant infections, resulting in a portfolio of 6 products at various stages of clinical development and commercialization, each of which have been granted Qualified Infectious Disease Product status by the US FDA.

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