Wockhardt seeks DCGI nod for Zaynich
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Drugmaker Wockhardt on Friday said that it has filed for regulatory approval of its Zaynich with the Drug Controller General of India (DCGI), with a domestic launch expected in the second half of the current fiscal.
The drugmaker also revealed plans to file New Drug Application (NDA) in USA by August following a successful pre-NDA (non-disclosure agreement) meeting with the US Food and Drug Administration (USFDA). If approved, the company aims for a U.S. launch in FY2026-27.
In addition to India and the U.S., Wockhardt is preparing to seek regulatory approvals in Europe and emerging markets in the second half of the current fiscal year.
The company has an addressable market opportunity of USD 7 billion in the US and Europe.
The antibiotic, to be used against gram-negative infections, is expected to help 11 lakh cases in India alone, PTI reported.
In Phase III study in hospitalized complicated urinary tract infection (cUTI) patients, Wockhardt’s Zaynich has demonstrated the highest-ever efficacy achieving a clinical cure rate of 96.8%. The study enrolled 529 patients with complicated urinary tract infection (cUTI) and Acute Pyelonephritis (AP) and was conducted in US, Europe, LATAM, China, India, spanning 64 sites. In this study, Zaynich® demonstrated superiority over gold standard meropenem, achieving a composite clinical and microbiology cure rate of 89.0% vs 68.4% respectively. These results were based on primary endpoints defined by both the US FDA and EMA.
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