Achaogen’s Zemdri (plazomicin) Receives FDA Approval for Complicated Urinary Tract Infection (cUTI)

Achaogen’s Zemdri (plazomicin) Receives FDA Approval for Complicated Urinary Tract Infection (cUTI)

Shots:

  • The approval is based on P-III EPIC (Evaluating Plazomicin in cUTI) study results assessing Zemdri (plazomicin, IV) vs Meropenem in 388 patients with cUTI including pyelonephritis aged ≥18 yrs.
  • P-IIIEPIC study results: composite cure rate (CCR) @5 day (88.0% vs 91.4%); CCR at test-of-cure (TOC) (81.7% vs 70.1%)
  • Zemdri (plazomicin, qd) is an aminoglycoside active against carbapenem-resistant (CRE) & extended spectrum beta-lactamase (ESBL) producing Enterobacteriaceae used for targetting bacterias including E.coli, Klebsiella pneumoniae and Enterobacter cloacae 

Click here to read full press release/ article | Ref: Achaogen | Image: Achaogen