Shots:
- The US FDA has approved Zaynich (Cefepime and Zidebactam) for treating adults with complicated urinary tract infections (cUTIs), including pyelonephritis, caused by susceptible Gram-negative bacteria
- Approval was based on a P-III (ENHANCE-1) trial in 530 adults with cUTI or acute pyelonephritis across 64 global sites, where Zaynich demonstrated superior clinical and microbiological response rates vs. meropenem (89.0% vs. 68.4%) and was generally well tolerated
- Zaynich is an injectable antibiotic combining the cephalosporin cefepime with zidebactam, a non-β-lactam antibacterial and β-lactamase inhibitor. Wockhardt has also submitted an MAA to the EMA
Ref: Wockhardt| Image: Wockhardt| Press Release
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