The European Medicines Agency (EMA) has confirmed that Wockhardt’s antibiotic candidate WCK 5222, a combination of Zidebactam and Cefepime, qualifies for Accelerated Assessment following a pre-submission meeting with the agency’s review team.
The accelerated review status reflects the EMA’s assessment that WCK 5222 could address a significant unmet medical need by offering a new treatment option for serious and life-threatening infections caused by multi-drug-resistant and extremely drug-resistant Gram-negative bacteria. The proposed indications include complicated urinary tract infections, hospital-acquired and ventilator-associated pneumonia, complicated intra-abdominal infections, and bloodstream infections linked to these conditions. The therapy is also intended for adult patients with limited treatment options against aerobic Gram-negative infections.
During scientific discussions, the EMA highlighted the novel beta-lactam enhancer mechanism of WCK 5222 and its ability to overcome multiple resistance pathways in Gram-negative pathogens. Based on available non-clinical, clinical, and pharmacokinetic-pharmacodynamic data, the EMA confirmed eligibility for accelerated assessment under Article 14(9) of Regulation (EC) No 726/2004.
If approved, WCK 5222 would support treatment across a broad range of severe infections and help address the growing global challenge of antimicrobial resistance. The submission marks the first time a new chemical entity discovered and developed in India has been filed for pan-European marketing authorization.
Marketed as Zaynich®, the Zidebactam/Cefepime combination has completed a global Phase III clinical trial and has been submitted for regulatory approval in the United States, India, and Europe. Wockhardt has treated more than 50 patients in India and the U.S. under compassionate use programs. With over 27 years of antibiotic research experience, Wockhardt maintains a strong pipeline of novel antibiotics and operates manufacturing and research facilities across India, Europe, and the United States, with international markets contributing the majority of its revenue.
