newsio aggregates and links to original sources. We do not own the original images or content. If you believe content infringes on intellectual property rights, contact us — it will be removed at first notice.
biotech/news//Devdiscourse
Wockhardt Ltd has been granted approval to market its innovative antibiotic, Zaynich, in India.
Wockhardt Ltd received CDSCO approval to market Zaynich for severe UTIs in India.
KEY POINTS
Zaynich combines Zidebactam and Cefepime, targeting complex UTIs including Gram-negative bacteremia.
The ENHANCE-1 Phase 3 trial showed Zaynich's efficacy comparable to meropenem.
Phase 1 and 2 studies report over 97% clinical success for Zaynich in severe infections.
Wockhardt Ltd has been granted approval to market its innovative antibiotic, Zaynich, in India, the company announced on Thursday. This decision by the Central Drugs Standard Control Organisation (CDSCO) allows the pharmaceutical firm to introduce its treatment aimed at severe urinary tract infections (UTIs) in adult patients.
Zaynich combines Zidebactam and Cefepime, targeting complex UTIs including pyelonephritis and infections that lead to Gram-negative bacteremia. This significant step follows the completion of the ENHANCE-1 Phase 3 global clinical trial, which demonstrated Zaynich's efficacy compared to meropenem, a standard treatment for such bacterial infections.
Additionally, extensive testing including Phase 1 and Phase 2 studies showcased over 97% clinical success against various severe infections like hospital-acquired bacterial pneumonia. Wockhardt highlights Zaynich as a potentially crucial therapeutic option amidst rising antibiotic resistance in India.
(With inputs from agencies.)