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Wockhardt Limited announced that the European Medicines Agency (EMA) has granted Accelerated Assessment to its investigational drug, WCK 5222 (Zidebactam 1g + Cefepime 2g). This designation follows a pre-submission meeting with the EMA review team and signifies the EMA's view that WCK 5222 has the potential to address an unmet medical need for serious and life-threatening infections, particularly those caused by multi-drug-resistant (MDR) and extremely drug-resistant (XDR) Gram-negative pathogens.

The drug is being considered for indications including complicated urinary tract infections (cUTI), hospital-acquired pneumonia (HAP), complicated intra-abdominal infections (cIAI), and treatment of infections due to aerobic Gram-negative organisms in adult patients with limited treatment options. The EMA noted the novel mechanism of action of WCK 5222 in overcoming resistance mechanisms in Gram-negative bacteria, based on a comprehensive review of non-clinical, clinical, and pharmacokinetic-pharmacodynamic data.

If approved, WCK 5222 would be the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorization. WCK 5222, also known as Zaynich®, is a novel antibiotic combining Zidebactam and Cefepime. It has completed a global Phase III clinical trial, and its New Drug Application (NDA) has been accepted by the USFDA. Marketing authorization applications have also been filed with Indian regulatory authorities. Wockhardt has a strong pipeline of six antibiotics, with three already approved and two in final development stages.