A major tool in combating antimicrobial resistance could soon be on its way, all thanks to an Indian pharma powerhouse.

 

Wockhardt has announced that the European Medicines Agency (EMA) has granted Accelerated Assessment status to its novel antibiotic WCK 5222 (Zidebactam 1g + Cefepime 2g).

 

The EMA’s designation highlights the potential of WCK 5222 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.”

 

The accelerated review covers WCK 5222 for multiple critical infections, including complicated urinary tract infections (cUTI), including pyelonephritis, hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), complicated intra-abdominal infections (cIAI), bacteraemia associated with cUTI, HAP/VAP, or cIAI.

 

During the EMA discussions, the agency “noted the novel β-lactam enhancer mechanism of action of WCK 5222 and its relevance in overcoming a plethora of resistance mechanisms in Gram-negative bacteria.”

 

The agency concluded that, 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.”

 

Wockhardt emphasized that WCK 5222 is “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.”