Wockhardt Shares Surge Following CDSCO Approval for Novel Antibiotic
Wockhardt's Shares Surge 11 Percent After CDSCO Grants Marketing Authorization for Novel Antibiotic Zaynich
Shares of Wockhardt, a leading drugmaker, experienced a significant gain of 11 percent on Friday, following the announcement that the Central Drugs Standard Control Organisation (CDSCO) granted marketing authorization for its novel, indigenously developed breakthrough antibiotic, Zaynich, on May 28. Zaynich, a combination of Zidebactam and Cefepime given as an injection, has been granted approval for marketing in India to treat adult patients suffering from complicated urinary tract infections (cUTI), including pyelonephritis.
The regulatory nod clears the way for Wockhardt to market Zaynich in India, a significant development in the fight against antimicrobial resistance. The approval is supported by results from the pivotal ENHANCE-1 study, a multinational, randomized, double-blind Phase 3 clinical trial evaluating the efficacy and safety of Zaynich compared with meropenem in patients with cUTI, including pyelonephritis. The study demonstrated that patients on Zaynich achieved an 89 percent response rate, which includes clinical cure and microbiological eradication, compared to just 68.4 percent for the standard-of-care drug, meropenem.
The approval of Zaynich is particularly significant in India, where pyelonephritis is a major clinical challenge due to the prevalence of metallo-β-lactamase (MBL)-mediated resistance. Zaynich is uniquely positioned to target this resistance mechanism, which is one of the most prevalent and challenging in India. Current options like colistin and polymyxins are frequently limited by severe toxicity and poor efficacy.
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The benchmark BSE Sensex gained 0.33 percent to 76,147.58 points on Friday, with Wockhardt stock trading at Rs. 1948.90 at 9.20 am. Wockhardt's regulatory has also filed New Drug Application (NDA) for Zaynich in the US and European Union, which are currently under active review. The molecule has already secured Fast Track and Qualified Infectious Disease Product (QIDP) designations from the USFDA.
| Drug | Response Rate |
|---|---|
| Zaynich | 89% |
| Meropenem | 68.4% |
| Zaynich (high-risk patients) | 89% |
| Meropenem (high-risk patients) | 44% |
Note: The response rates are based on the results of the ENHANCE-1 study.
Investor Takeaway
Investors should consider Wockhardt's stock as it may benefit from the approval of its novel antibiotic.
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