Wockhardt has filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic, WCK 5222, on January 5, 2026. WCK 5222, a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g), is under accelerated assessment. The New Drug Application (NDA) for WCK 5222 is also under fast-track review by the US FDA, potentially offering a new treatment option for resistant Gram-negative infections.
European Submission for WCK 5222
Wockhardt has announced the successful filing of a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic, WCK 5222, on January 5, 2026. This submission marks a significant step in potentially bringing this new treatment option to patients across Europe.
Accelerated Assessment Pathway
The EMA had previously informed Wockhardt that WCK 5222, which is a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g), qualifies for Accelerated Assessment. This designation indicates the urgent need for the product and allows for a faster review process. The New Drug Application (NDA) for WCK 5222 is also currently undergoing fast-track review by the US FDA.
About Zaynich®
Zaynich® (Zidebactam/Cefepime, WCK 5222) is a novel antibiotic developed by Wockhardt, combining Zidebactam and Cefepime to combat multi-drug resistant Gram-negative infections. A global Phase III clinical trial has been completed to support marketing authorization across international markets. The NDA for Zaynich® has been filed with the USFDA. To date, more than 50 patients have been treated with Zaynich® under compassionate use programs in India and the U.S.
Wockhardt’s Antibiotic Pipeline
Wockhardt has focused on antibiotic innovation for over 27 years, with a commitment to combating multi-drug resistant infections. This has led to a pipeline of six antibiotics, all of which have been granted Qualified Infectious Disease Product (QIDP) designation by the U.S. FDA.
Source: BSE
