Wockhardt Ltd shares soared 19 per cent in Monday's trade, extending their one-month rally to 64 per cent, after the drug maker said the US Food and Drug Administration (US FDA) approved ZAYNICH, a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. 
The drug is a multi- penicillin-binding protein targeting combination of the 4th generation cephalosporin cefepime and zidebactam, having earlier received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.

Wockhardt rose 19.17 per cent to hit a high of Rs 2,420 on BSE. This was in addition to a 14.70 per cent jump on Friday.

Wockhardt said FDA approval was based, in part, on the results from ENHANCE-1, a Phase 3, randomized, double-blind, multicenter study which evaluated the efficacy, safety and tolerability of ZAYNICHTM compared with meropenem in the treatment of hospitalized adults with cUTI or acute pyelonephritis (AP). 

"ZAYNICHTM demonstrated efficacy at the primary endpoint, achieving a composite clinical cure and microbiological response rate of 89 per cent versus 68.4 per cent for meropenem Treatment difference 20.6 per cent (95 per cent CI; 12.3, 29.5). ZAYNICHTM was generally well tolerated in the phase 3 study. The study enrolled 530 patients from the US, Europe, LATAM, China and India, and spanned across 64 sites," said Wockhardt. 

Habil F Khorakiwala, Founder and Chairman of Wockhardt Group said the approval is a significant realisation of our mission to provide patients with novel antibiotics that help to address one of the most urgent global health threats—antimicrobial resistance. 

Earlier on May 28, the same drug had received the Central Drugs Standard Control Organisation (CDSCO) authorization for the import and marketing. 

"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 per cent 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," Wockhardt said.