Wockhardt gets Indian marketing nod for ZAYNICH antibiotic
Wockhardt Ltd. announced that the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorization for its breakthrough antibiotic, ZAYNICH® (Zidebactam/Cefepime), in India. This approval is for treating complicated urinary tract infections (cUTI) in adults, including pyelonephritis with concurrent Gram-negative bacteremia. The authorization is supported by the pivotal ENHANCE-1 Phase 3 clinical trial, where ZAYNICH® demonstrated statistical superiority over meropenem, achieving the primary endpoint in 89% of patients compared to 68.4% for meropenem. ZAYNICH® is crucial for addressing metallo-β-lactamase (MBL)-mediated resistance and extensively drug-resistant (XDR) Gram-negative pathogens, offering a vital therapeutic option where current treatments are limited by toxicity or suboptimal efficacy. Submissions for New Drug Application (NDA) in the US and Marketing Authorisation Application (MAA) in the EU are also underway.
Key Highlights
- Indian regulator CDSCO grants marketing authorization for Wockhardt's ZAYNICH® antibiotic.
- ZAYNICH® approved for complicated urinary tract infections in adults.
- Phase 3 trials showed ZAYNICH® superior to meropenem with 89% efficacy.
- Drug addresses critical unmet need for drug-resistant Gram-negative infections.
- New Drug Application in US and Marketing Authorisation Application in EU are submitted.
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