Wockhardt Gets CDSCO Nod for Antibiotic Zaynich in Complicated UTIs

New Delhi: Wockhardt Ltd on Thursday said it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its newly developed antibiotic, Zaynich, in India.

The drug, a combination of Zidebactam and Cefepime, has been approved for treating complicated urinary tract infections (UTI), including kidney infections, known as pyelonephritis, in adult patients.

The approval also covers cases where these infections are accompanied by Gram-negative bacteremia, a serious bloodstream infection caused by bacteria, according to a regulatory filing.

The regulatory nod is based on results from a global Phase 3 clinical trial called ENHANCE-1. The study compared Zaynich with meropenem, a commonly used antibiotic for severe bacterial infections, the company said in a release.

Prior to the Phase 3 programme, 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.

According to the company, 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.

Zaynich may also be effective against infections caused by metallo-β-lactamase (MBL)-producing bacteria, a major source of antibiotic resistance in India, the release added.