Wockhardt Submits Marketing Application for WCK 5222 to EMA
Filing Summary
Wockhardt Ltd has filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its antibiotic, WCK 5222, on January 5, 2026. The application seeks approval for the treatment of resistant Gram-negative infections across 30 countries under EMA’s jurisdiction. WCK 5222, a combination of Zidebactam and Cefepime, is eligible for Accelerated Assessment, allowing for a shortened review timeline. The drug is also under fast-track review by the US FDA. Wockhardt’s submission marks the first New Chemical Entity from India to seek pan-European marketing authorisation.
Wockhardt Ltd has 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 responsible for the scientific evaluation of new medicines across 27 European Union Member States and three European Economic Area countries, covering a total of 30 countries. The application aims to secure approval for the treatment of resistant Gram-negative infections.
The filing does not disclose specific financial terms or payment structures related to the application process or potential market entry. The focus remains on the regulatory submission and the strategic importance of gaining approval in the European market.
WCK 5222 is a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g). The EMA has informed Wockhardt that the drug is eligible for Accelerated Assessment, which allows for an abridged review timeline due to the unmet medical need addressed by the product. The New Drug Application (NDA) for WCK 5222 is already under fast-track review by the US FDA. The drug has completed a global, pivotal Phase III clinical trial, which supports its marketing authorization across international markets.
Wockhardt’s submission of WCK 5222 is significant as it is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation. The priority review status granted to WCK 5222 underscores the global urgency to provide effective treatment options for patients suffering from life-threatening multi-drug resistant infections. The drug has also been filed for marketing authorization with Indian regulatory authorities.
The timeline for the EMA’s review process has not been specified in the filing. However, the Accelerated Assessment pathway suggests a shortened timeline compared to standard procedures. The application includes comprehensive clinical and regulatory data to support the approval process.
Wockhardt has been engaged in antibiotic innovation for over 27 years, focusing on combating multi-drug resistant infections. The company has a strong pipeline of six antibiotics at various stages of clinical development and commercialization, all of which have been granted Qualified Infectious Disease Product (QIDP) designation by the US FDA. Three of these antibiotics are already approved for clinical use, while two more are in the final stages of development.