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Wockhardt’s WCK 5222 gets Accelerated Assessment grant from European Medicines Agency
Dec-31-2025

Wockhardt’s WCK 5222 (combination of Zidebactam 1g + Cefepime 2g) has been granted Accelerated Assessment by The European Medicines Agency (EMA). The Accelerated Assessment designation reflects EMA’s view that WCK 5222 has the potential to address an unmet medical need by providing an effective therapeutic option for the treatment of serious and life-threatening infections, particularly those caused by multi-drug-resistant (MDR) and extremely drug-resistant (XDR) Gram negative pathogens. 

WCK 5222 can be used to address Complicated urinary tract infections (cUTI), including pyelonephritis, Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) and Complicated intra-abdominal infections (cIAI). Further, it can be used for treatment of patients with bacteraemia occurring in association with, or suspected to be associated with, cUTI/acute pyelonephritis, HAP/VAP, or cIAI and treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. 

If approved, the proposed breadth of indications would support the use of WCK 5222 across a wide range of serious infections and contribute to addressing the growing public health challenge of antimicrobial resistance. WCK 5222 represents the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation, reflecting the advancement of an India-initiated global antimicrobial innovation efforts.

Wockhardt is a research based Global Pharmaceutical and Biotech company.

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