Wockhardt announced that its novel antibiotic, Zaynich® (Zidebactam/Cefepime), has received a favourable recommendation from the CDSCO’s Subject Expert Committee (SEC) for marketing permission in India. This positive opinion is a crucial step toward final approval by the DCGI for treating Gram-negative infections. The antibiotic is developed using a novel $\beta$-lactam enhancer mechanism, showing strong efficacy in global Phase 3 trials.
Positive Regulatory Step for Novel Antibiotic
Wockhardt has received a significant endorsement for its novel antibiotic candidate, Zaynich® (Zidebactam/Cefepime). The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has granted a favourable recommendation for marketing permission concerning the treatment of Gram-negative infections. This recommendation moves the product closer to final approval from the Drugs Controller General of India (DCGI).
Comprehensive Development and Efficacy Data
The recommendation follows a thorough review of extensive data, including non-clinical studies, nine Phase 1 trials, a multi-indication Phase 2 study in meropenem-resistant infections, and a global Phase 3 study covering complicated urinary tract infections and acute pyelonephritis. Zaynich® was developed over 15 years by a team of over 150 scientists.
The drug features a novel $\beta$-lactam enhancer-based mechanism designed to offer unprecedented coverage against MDR/XDR Gram-negative pathogens prevalent in India. The Phase 3 study demonstrated superiority over meropenem in combined clinical and microbiological cure.
Global Clinical Reach and Advanced Status
The global clinical program involved nine Phase 1 studies across the United States and China, involving nearly 300 subjects, followed by a Phase 3 study in 530 patients across 64 sites in the US, Europe, Latin America, China, and India.
Furthermore, Wockhardt confirmed strong efficacy in 85 XDR Gram-negative infection cases treated under compassionate use across India, the US, and Malaysia. The Clinical and Laboratory Standards Institute (CLSI) has set an investigational susceptible breakpoint of 64 mg/L for Zidebactam/Cefepime.
In parallel global efforts, a New Drug Application (NDA) has been submitted in the United States, and a Marketing Authorisation Application (MAA) has been submitted in the European Union, both currently in advanced stages of review.
Wockhardt’s Drug Discovery Focus
Over the past 25 years, Wockhardt has heavily focused on discovering new medicines for multi-drug resistant infections. This effort has resulted in a portfolio of 6 products at various clinical development and commercialization stages, all of which have been granted Qualified Infectious Disease Product (QIDP) status by the US FDA.
Source: BSE
