Wockhardt Limited announced that the Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorization for its indigenously discovered antibiotic ZAYNICH (Zidebactam/Cefepime) in India for treating complicated urinary tract infections (cUTI), including pyelonephritis, and concurrent Gram-negative bacteremia in adult patients.
The approval is based on the pivotal ENHANCE-1 study (NCT04979806), a multinational Phase 3 trial where Zaynich showed statistical superiority over meropenem. The primary endpoint of clinical cure and microbiological eradication was achieved in 89% (250/281) of patients treated with Zaynich, compared to 68.4% (93/136) in the meropenem arm. Among patients with concomitant bacteremia at baseline, composite response rates were 89% (16/18) for Zaynich versus 44% (4/9) for meropenem.
Prior to the Phase 3 program, Zaynich was evaluated in nine Phase 1 studies and a Phase 2 study across 15 Indian hospitals, demonstrating over 97% clinical efficacy in serious infections such as hospital-acquired pneumonia and bloodstream infections.
Zaynich addresses metallo-beta-lactamase-mediated resistance, a prevalent mechanism in India. Under compassionate use, Zaynich has demonstrated clinical efficacy in 85 cases of extensively drug-resistant Gram-negative infections across India, the United States, Malaysia, and France. Zaynich has received Priority Review, Fast Track, and QIDP designations from the US FDA. A New Drug Application in the United States and a Marketing Authorisation Application in the European Union for Cefepime/Zidebactam are under regulatory review.
Wockhardt has a pipeline of six antibiotics, all granted QIDP designation by the US FDA, with three targeting Gram-negative and three targeting Gram-positive pathogens.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.