Wockhardt has successfully filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic WCK 5222 on January 5, 2026.

The EMA is the central regulatory authority responsible for the scientific evaluation of new medicines across 27 European Union (EU) member states and three European Economic Area (EEA) countries—Iceland, Liechtenstein, and Norway—covering a total of 30 countries.

Earlier, the EMA had informed Wockhardt that WCK 5222, a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g), is eligible for Accelerated Assessment. This regulatory pathway enables a shortened review timeline, recognising the significant unmet medical need addressed by the therapy. Notably, the New Drug Application (NDA) for WCK 5222 is also under fast-track review by the US Food and Drug Administration.

Based on the robust clinical and regulatory data submitted, Wockhardt expects approval of WCK 5222 for the treatment of resistant Gram-negative infections across all countries under the EMA’s jurisdiction. The priority review status highlights the global urgency to make effective therapies available for patients suffering from life-threatening multidrug-resistant infections.

Importantly, WCK 5222 marks a significant milestone as the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation, reinforcing India’s growing capabilities in advanced pharmaceutical innovation.