CDSCO Grants Marketing Authorization to Wockhardt’s Antibiotic Zaynich®

CDSCO Grants Marketing Authorization to Wockhardt’s Antibiotic Zaynich®​

Wockhardt Ltd. announced that the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorization for the import and sale of its antibiotic, Zaynich ® (Zidebactam/Cefepime). The breakthrough drug is designed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, and cases involving concurrent Gram-negative bacteremia in adult patients (≥18 years).

The approval recognizes Zaynich ® as an indigenously discovered and developed, first-in-class antibiotic.

Strong Clinical Efficacy Demonstrated in Phase 3 Trial​

The regulatory approval is supported by outcomes from the pivotal ENHANCE-1 study (NCT04979806). This multinational, randomized, double-blind Phase 3 clinical trial compared the efficacy and safety of Zaynich ® against meropenem in patients suffering from cUTI, including pyelonephritis.

In the study, patients were randomized in a 2:1 ratio to receive either Zaynich ® or meropenem. 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 performance metrics were as follows:

Targeting Resistant and Severe Infections​

The drug's potential is particularly highlighted in cases with concomitant bacteremia at baseline, where the composite response rate was 89% in the Zaynich ® arm compared to 44% in the meropenem arm.

Before the Phase 3 program, Zaynich ® underwent evaluation across nine Phase 1 studies and a Phase 2 clinical study. The Phase 2 study, conducted across 15 leading tertiary care hospitals in India, demonstrated over 97% clinical efficacy against serious infections, including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and cUTI.

Zaynich ® is noted for its ability to address metallo-β-lactamase (MBL)-mediated resistance, a critical and challenging resistance mechanism in India. This positions the antibiotic as a potential life-saving option, especially in carbapenem-resistant infections where treatments like colistin and polymyxins have limitations due to toxicity and efficacy concerns.

The combination of Zidebactam and Cefepime acts through multiple binding points, with Zidebactam selectively inhibiting penicillin-binding protein-2 (PBP2) and Cefepime primarily targeting penicillin-binding protein-3 (PBP3) in Gram-negative bacterial pathogens.

Global Recognition and Development​

Globally, the development of Cefepime/Zidebactam remains advanced. The Clinical and Laboratory Standards Institute assigned an investigational susceptible breakpoint of 64 mg/L, supporting its potential use against extensively drug-resistant (XDR) Gram-negative pathogens.

Further clinical utility is underscored by the fact that 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. The product has also achieved significant designations from the US FDA, including Priority Review, Fast Track, and Qualified Infectious Disease Product (QIDP) status for various infections such as cUTI, cIAI, and HABP/VABP.

Wockhardt, a global pharmaceutical and biotechnology company, specializes in developing innovative anti-infective solutions. The company has a focused commitment to combating antimicrobial resistance, which is evident in its pipeline of six antibiotics. Three of these antibiotics target Gram-Negative pathogens, and three target Gram-Positive pathogens. These remaining six antibiotics have all been granted the Qualified Infectious Disease Product (QIDP) designation by the US FDA. The firm’s global operations show that 78% of its total revenue is generated from international businesses.

WOCKPHARMA Stock Price Movement​

On Wednesday, Wockhardt Limited shares edged higher, closing at ₹1771 after gaining ₹79.90, representing a 4.70% jump for the session. The stock traded on a considerable volume of 1.96 million shares.