USFDA31 Dec 2025, 12:29 pm
European Medicines Agency Grants Accelerated Assessment to Wockhardt's WCK 5222
AI Summary
The European Medicines Agency (EMA) has granted Accelerated Assessment to WCK 5222, a combination of Zidebactam 1g + Cefepime 2g, developed by Wockhardt Ltd. The designation is given 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 drug has completed a global, pivotal Phase 111 clinical trial and the New Drug Application (NDA) has been filed and accepted by the USFDA. The application for Marketing Authorization has also been filed with the Indian regulatory authorities.
Key Highlights
- WCK 5222 eligible for Accelerated Assessment by EMA
- Potential to address unmet medical need for serious and life-threatening infections
- First NCE discovered and developed in India for pan-European marketing authorisation
- Completed global, pivotal Phase 111 clinical trial
- NDA filed and accepted by USFDA, application for Marketing Authorization filed with Indian regulatory authorities