Wockhardt's shares are higher by 10% after its widely-tracked discovery product Zaynich has achieved a 96.8% efficacy in the Phase III study for a complicated Urinary Tract Infection.
"With respect to clinical cure, Zaynich achieved 96.8% efficacy. Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in last more than 10 years," a statement by Wockhardt said.
Wockhardt said Zaynich's combined efficacy of clinical as well as microbiologic cure is 'highest ever' among all the FDA-approved novel antibiotics developed in the last 'more than 10 years'. In the trial, Zaynich was compared with meropenem, a broad-spectrum antibiotic, and met the DCGI-concurred and USFDA/EMA pre-specified primary efficacy results.
Wockhardt now intends to file a new drug application (NDA) with the USFDA and seek marketing authorization application with European Medicines Agency (EMA).
Zidebactam/Cefepime, or Zaynich, an investigational antibiotic categorised under the novel class of 'β-lactam enhancers', has been under evaluation for its efficacy in treating complicated urinary tract infections, including acute pyelonephritis.
The pharma company had previously said that the Phase III clinical trial for Zaynich was to complete by the first quarter of 2025. Even before its formal approval, Wockhardt's Zaynich has drawn global interest and request for supply of the the drug for compassionate use in US, UK, France, Australia, and Malaysia.
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