The European Medicines Agency (EMA) has informed Wockhardt that WCK 5222 (combination of Zidebactam 1g + Cefepime 2g) is eligible for Accelerated Assessment, following a pre-submission meeting with the EMA review team.

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 following serious and life-threatening infections, particularly those caused by Multi-Drug-Resistant (MDR) and Extremely Drug-Resistant (XDR) gram-negative pathogens. These include complicated Urinary Tract Infections (cUTI), including pyelonephritis; Hospital-Acquired Pneumonia (HAP), including Ventilator-Associated Pneumonia (VAP); complicated Intra-Abdominal Infections (cIAI); 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.

During the scientific review discussions, EMA noted the novel β-lactam enhancer mechanism of action of WCK 5222 and its relevance in overcoming plethora of resistance mechanisms in gram-negative bacteria. Based on the totality of available non-clinical, clinical and pharmacokinetic-pharmacodynamic (PK-PD) data, EMA has concurred that WCK 5222 is eligible for accelerated assessment pursuant to Article 14 (9) of Regulation (EC) no 726/2004.

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 (AMR).

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.