European Medicines Agency (EMA) has informed Wockhardt Limited that its investigational antibiotic WCK 5222, a combination of Zidebactam (1g) and Cefepime (2g), is eligible for Accelerated Assessment following a pre-submission meeting with the agency’s review team.

The Accelerated Assessment designation reflects EMA’s view that WCK 5222 has the potential to address a significant unmet medical need by offering an effective treatment option for 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, including pyelonephritis; hospital-acquired pneumonia, including ventilator-associated pneumonia; complicated intra-abdominal infections; bacteraemia associated with or suspected to be linked to these conditions; and infections due to aerobic Gram-negative organisms in adult patients with limited treatment options.

During scientific review discussions, the EMA highlighted the novel á-lactam enhancer mechanism of action of WCK 5222 and its potential role in overcoming multiple resistance mechanisms in Gram-negative bacteria. Based on the overall non-clinical, clinical and pharmacokinetic-pharmacodynamic data, the regulator concurred that the drug qualifies for accelerated assessment under Article 14(9) of Regulation (EC) No 726/2004.

If approved, the broad scope of indications could enable the use of WCK 5222 across a wide range of serious infections and contribute meaningfully to addressing the growing global challenge of antimicrobial resistance. Notably, WCK 5222 is the first new chemical entity discovered and developed in India to be submitted for pan-European marketing authorisation, underscoring the progress of India-led global antimicrobial innovation efforts.