Wockhardt Files Marketing Authorisation Application for Novel Antibiotic WCK 5222 with European Medicines Agency
Wockhardt Limited, a leading pharmaceutical company, has successfully filed a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic, WCK 5222. The EMA is responsible for the scientific evaluation of new medicines across 30 countries. WCK 5222, a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g), is eligible for Accelerated Assessment, reflecting the unmet medical need addressed by the product. The New Drug Application (NDA) on WCK 5222 is already under fast-track review by the US FDA. The priority review status granted to WCK 5222 underscores the global urgency to make effective treatment options available for patients suffering from life-threatening multi-drug resistant infections. Zaynich®, the brand name for WCK 5222, is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation.
Key Highlights
- Wockhardt has filed a Marketing Authorisation Application (MAA) for its novel antibiotic, WCK 5222, with the European Medicines Agency (EMA).
- WCK 5222 is a fixed-dose combination of Zidebactam (1 g) and Cefepime (2 g).
- WCK 5222 is eligible for Accelerated Assessment by the EMA, reflecting the unmet medical need addressed by the product.
- The New Drug Application (NDA) on WCK 5222 is already under fast-track review by the US FDA.
- Zaynich®, the brand name for WCK 5222, is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation.