Wockhardt Receives CDSCO Approval for Novel Antibiotic Zaynich in India  

Key Highlights: 

• Wockhardt has received CDSCO approval for the import and marketing of Zaynich (zidebactam/cefepime), an indigenously discovered first-in-class antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis and associated Gram-negative bacteremia. The approval positions Zaynich as a potential new option against multidrug-resistant Gram-negative infections in India. 

• The approval was supported by data from the global Phase III ENHANCE-1 trial, which evaluated Zaynich against meropenem in patients with cUTI. The study met its primary endpoint, with clinical cure and microbiological eradication achieved in 89% (250/281) of patients receiving Zaynich vs 68.4% (93/136) in the meropenem arm, demonstrating a treatment difference of 20.6% in favor of Zaynich. In patients with concurrent bacteremia, response rates at the test-of-cure visit reached 89% with Zaynich compared to 44% with meropenem. 

• Prior to Phase III development, Zaynich was evaluated in nine Phase I studies and a Phase II study across 15 tertiary hospitals in India involving meropenem-resistant Gram-negative infections. The Phase II trial demonstrated over 97% clinical efficacy across HABP, VABP, bloodstream infections, cIAI, and cUTI. The therapy is specifically positioned to address metallo-β-lactamase (MBL)-mediated resistance, a major antimicrobial resistance challenge in India, while the Clinical and Laboratory Standards Institute has assigned cefepime/zidebactam an investigational susceptible breakpoint of 64 mg/L for coverage of extensively drug-resistant Gram-negative pathogens. 

Implications: 

Zaynich’s approval gives Wockhardt a home-grown differentiated anti‑infective positioned squarely at India’s metallo‑β‑lactamase (MBL) and XDR Gram‑negative crisis, rather than just another cUTI entrant. 

Source: Wockhardt