You are currently viewing Wockhardt Gains After India Approves New Antibiotic Zaynich for Drug-Resistant Infections
The image used is for informational purposes only. Image Source: https://www.ndtvprofit.com/

Wockhardt Gains After India Approves New Antibiotic Zaynich for Drug-Resistant Infections

Prime Highlights

  • CDSCO approved Wockhardt’s antibiotic Zaynich® for treating complicated urinary tract infections and Gram-negative bacteremia in adults.
  • Phase 3 trial results showed Zaynich® delivered significantly higher cure and eradication rates than meropenem.

Key Facts

  • Wockhardt Ltd. is an Indian pharmaceutical company focused on developing medicines, vaccines, and advanced healthcare solutions.
  • Zaynich® (Zidebactam/Cefepime) is an India-developed first-in-class antibiotic designed to fight drug-resistant Gram-negative bacterial infections.

Background

Wockhardt Ltd. shares surged more than 9% in late May after the Central Drugs Standard Control Organisation (CDSCO) approved the import and marketing of Zaynich® (Zidebactam/Cefepime) in India. The antibiotic has been cleared for treating adults suffering from complicated urinary tract infections (cUTI), including pyelonephritis, as well as infections linked with Gram-negative bacteremia.

The company said Zaynich® is a first-in-class antibiotic discovered and developed in India to combat drug-resistant Gram-negative bacterial infections. The approval follows results from the global Phase 3 ENHANCE-1 clinical trial, which compared the drug with meropenem in patients with complicated urinary tract infections.

Trial data showed that Zaynich® outperformed meropenem on the primary endpoint of clinical cure and microbiological eradication. The success rate of patients using Zaynich® was around 89%, whereas the rate of patients responding to meropenem was 68.4%. When considering the percentage of patients responding to therapy in case of bacteremia, it was noted that patients responded well to treatment with a success rate of 89% when using Zaynich® and only 44% when using meropenem.

Before starting its Phase 3 trials, Zaynich® went through nine Phase 1 and one Phase 2 trial in 15 tertiary care hospitals in India. In Phase 2, the antibiotic showed efficacy greater than 97% in treating several severe infections, such as hospital-acquired pneumonia, ventilator-associated pneumonia, bacteremia, complicated intra-abdominal infections, and cUTI.

As mentioned by Wockhardt, this antibiotic can serve as an alternative to patients with infections caused by carbapenem-resistant organisms. Additionally, the company has highlighted that it can help in tackling metallo-β-lactamase-mediated resistance and extensive drug resistance.