The European Medicines Agency (EMA) has granted Wockhardt’s WCK 5222 (Zidebactam + Cefepime combination) accelerated assessment designation. This decision recognizes WCK 5222’s potential to address unmet medical needs in treating serious and life-threatening infections caused by multi-drug-resistant Gram-negative pathogens. The EMA highlighted the novel mechanism of action and the available data supporting the treatment’s effectiveness.
EMA Recognition for WCK 5222
The European Medicines Agency (EMA) has informed Wockhardt that WCK 5222, a combination of Zidebactam and Cefepime, is eligible for Accelerated Assessment. This follows a pre-submission meeting with the EMA review team, marking a significant step in the drug’s potential approval and availability in Europe.
Targeting Resistant Infections
The accelerated assessment reflects the EMA’s view that WCK 5222 could provide a valuable therapeutic option for serious and life-threatening infections. These include infections caused by multi-drug-resistant (MDR) and extremely drug-resistant (XDR) Gram-negative pathogens. Specifically, the treatment is intended for:
- Complicated urinary tract infections (cUTI)
- Hospital-acquired pneumonia (HAP)
- Complicated intra-abdominal infections (cIAI)
- Bacteraemia associated with cUTI/HAP/cIAI
- Infections due to aerobic Gram-negative organisms with limited treatment options
Novel Mechanism of Action
The EMA’s decision was influenced by the novel β-lactam enhancer mechanism of action of WCK 5222. This mechanism is important for overcoming resistance in Gram-negative bacteria. EMA has agreed that WCK 5222 is eligible for accelerated assessment under Article 14 (9) of Regulation (EC) no 726/2004.
About Zaynich®
Zaynich® (Zidebactam/Cefepime, WCK 5222) is a novel antibiotic developed by Wockhardt to combat multi-drug resistant Gram-negative infections. The New Drug Application (NDA) for Zaynich® has already been filed and accepted by the USFDA. A Marketing Authorization application has also been filed with Indian regulatory authorities. Clinical trials and studies have been conducted in the US and India.
Wockhardt’s Antibiotic Innovation
Wockhardt has been focused on antibiotic innovation for over 27 years, aiming to combat multi-drug resistant infections. This has resulted in a pipeline of six antibiotics, all of which have been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA. Three are already approved for clinical use, and two more are in the final stages of development.
Source: BSE
