CDSCO grants marketing authorization to Wockhardt's breakthrough antibiotic, ZAYNICH®

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 Gramnegative 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.

Shares of Wockhardt Limited was last trading in BSE at Rs. 1771.65 as compared to the previous close of Rs. 1703.95. The total number of shares traded during the day was 163464 in over 7761 trades.

The stock hit an intraday high of Rs. 1787.95 and intraday low of 1705.25. The net turnover during the day was Rs. 285302676.00.

Source : Equity Bulls

Keywords

Wockhardt INE049B01025 Pharmaceuticals CDSCO MarketingAuthorization Antibiotic ZAYNICH