Mumbai: Wockhardt Ltd. today announced that the Central Drugs Standard Control Organisation (CDSCO) has granted authorization for the import and marketing of its indigenously discovered and developed, first-in-class breakthrough antibiotic, Zaynich® (Zidebactam / Cefepime) in India. The approval is for the treatment of adult patients (≥18 years) with complicated urinary tract infections (cUTI), including pyelonephritis, as well as cases with concurrent Gram- negative bacteremia.
The approval is supported by results from the pivotal ENHANCE-1 study (NCT04979806), a multinational, randomized, double-blind Phase 3 clinical trial evaluating the efficacy and safety of Zaynich® compared with meropenem in patients with cUTI, including pyelonephritis. Patients were randomized in a 2:1 ratio to receive Zaynich® or meropenem. In this study, Zaynich® demonstrated statistical superiority over meropenem for the primary composite endpoint of clinical cure and microbiological eradication at the test-of-cure (TOC) visit. The primary endpoint was achieved in 89% (250/281) of patients treated with Zaynich®, compared to 68.4% (93/136) in the meropenem arm, with a treatment difference of 20.6% in favour of Zaynich®. The TOC assessment was conducted approximately 10 days after completion of therapy.
Notably, among patients with concomitant bacteremia at baseline, composite response rates at TOC were 89% (16/18) in the Zaynich® arm versus 44% (4/9) in the meropenem arm, underscoring its potential in severe and high-risk infections.
Prior to the Phase 3 program, Zaynich® was evaluated across nine Phase 1 studies and a Phase 2 clinical study involving patients with documented meropenem-resistant Gram-negative infections. This Phase 2 study, conducted across 15 leading tertiary care hospitals in India, demonstrated over 97% clinical efficacy across serious infections including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and cUTI.
These findings highlight the potential of Zaynich® as a life-saving therapeutic option, particularly in carbapenem-resistant infections where current treatment options such as colistin and polymyxins are limited by significant toxicity and suboptimal efficacy. Importantly, Zaynich® is uniquely positioned to address metallo-β-lactamase (MBL)-mediated resistance, one of the most prevalent and challenging resistance mechanisms in India.
In recognition of its broad-spectrum potential, the Clinical and Laboratory Standards Institute has assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, supporting its potential to cover clinically important extensively drug-resistant (XDR) Gram-negative pathogens in critically ill patients.
