The drug has been approved for the treatment of adult patients with complicated urinary tract infections (cUTI), including pyelonephritis, as well as infections accompanied by Gram-negative bacteremia.
According to the company, Zaynich® is an indigenously discovered and developed first-in-class antibiotic designed to tackle drug-resistant Gram-negative infections.
The approval is based on data from the pivotal ENHANCE-1 study, a multinational, randomised, double-blind Phase 3 clinical trial that evaluated the efficacy and safety of Zaynich® against meropenem in patients suffering from cUTI, including pyelonephritis.
Patients in the study were randomised in a 2:1 ratio to receive either Zaynich® or meropenem.
The trial showed that Zaynich® was statistically superior to meropenem on the primary endpoint of clinical cure and microbiological eradication at the test-of-cure visit, which was conducted around 10 days after completion of therapy.
The primary endpoint was achieved in 89% of patients treated with Zaynich®, compared to 68.4% in the meropenem arm, resulting in a treatment difference of 20.6% in favour of Zaynich®.
Among patients who had concurrent bacteremia at baseline, response rates at the test-of-cure visit stood at 89% in the Zaynich® arm, compared to 44% in the meropenem arm, highlighting its potential in severe and high-risk infections.
Before entering the Phase 3 programme, Zaynich® was evaluated in nine Phase 1 studies and a Phase 2 trial involving patients with documented meropenem-resistant Gram-negative infections.
The Phase 2 study was conducted across 15 tertiary care hospitals in India and demonstrated over 97% clinical efficacy across serious infections such as hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), bloodstream infections (BSI), complicated intra-abdominal infections (cIAI), and cUTI.
Wockhardt said these findings highlight Zaynich®’s potential as a life-saving treatment option, especially for carbapenem-resistant infections where currently available therapies such as colistin and polymyxins are associated with high toxicity and limited efficacy.
The company added that Zaynich® is uniquely positioned to address metallo-β-lactamase (MBL)-mediated resistance, one of the most challenging and prevalent resistance mechanisms in India.
The Clinical and Laboratory Standards Institute has also assigned Cefepime/Zidebactam an investigational susceptible breakpoint of 64 mg/L, supporting its potential use against extensively drug-resistant Gram-negative pathogens in critically ill patients.
