Wockhardt's Zaynich Achieves Highest-Ever Efficacy in cUTI Global Phase III Study

Wockhardt's Zaynich (Zidebactam/Cefepime, WCK 5222) has successfully completed a global, pivotal, registration-enabling Phase III study, demonstrating superiority compared with meropenem in the treatment of complicated urinary tract infection (cUTI). Zaynich achieved a 96.8% clinical cure rate, the highest ever among all FDA-approved novel antibiotics developed in the last more than 10 years. The study enrolled 530 cUTI patients from the US, Europe, LATAM, China, and India, and Zaynich showed clinical efficacy of 96.8% at test of cure (TOC, 7-10 days after last dose). Wockhardt plans to file new drug application (NDA) with US FDA and marketing authorization application (MAA) with EMA. Zaynich has the potential to treat a broad range of patients with cUTI due to multidrug-resistant (MDR) or extensively drug-resistant (XDR) pathogens.