Shares of Wockhardt are likely to remain in focus on Wednesday, December 31, after the company announced that the European Medicines Agency (EMA) has granted Accelerated Assessment to its novel antibiotic WCK 5222, according to a regulatory filing.
In an exchange filing dated December 31, Wockhardt said the EMA has confirmed that WCK 5222, a combination of Zidebactam 1g and Cefepime 2g, is eligible for accelerated assessment following a pre-submission meeting with the EMA review team .
What does the accelerated assessment mean?
The accelerated assessment status reflects the EMA’s view that WCK 5222 has the potential to address unmet medical needs, particularly in treating serious and life-threatening infections caused by multi-drug-resistant (MDR) and extremely drug-resistant (XDR) Gram-negative pathogens.
The proposed indications include complicated urinary tract infections, hospital-acquired pneumonia including ventilator-associated pneumonia, complicated intra-abdominal infections, and associated bacteraemia cases, as outlined in the company’s press release .
Key scientific observations
During scientific review discussions, the EMA highlighted the novel β-lactam enhancer mechanism of WCK 5222 and its ability to overcome multiple resistance mechanisms in Gram-negative bacteria. Based on available non-clinical, clinical, and pharmacokinetic-pharmacodynamic data, the regulator concluded that the drug qualifies for accelerated review under European regulations .
Why this development matters
Wockhardt noted that WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation, marking a significant milestone for India-led antimicrobial innovation.
The drug, branded as Zaynich®, has completed a global pivotal Phase III clinical trial and has already seen its New Drug Application accepted by the US Food and Drug Administration, while applications have also been filed with Indian regulators.
Market focus
Investors are expected to track how this regulatory progress could influence Wockhardt’s future pipeline visibility and global regulatory momentum, especially in the antimicrobial resistance space.
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