FDA New Drug and Biologic Approvals, 2018 Midyear Review

Urinary Tract Infection: Zemdri (plazomicin)

Indication: Indicated for complicated urinary tract infections (cUTIs) in adults, including pyelonephritis caused by the following susceptible microorganism(s): E coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae.

Mechanism: Aminoglycoside antibiotic that has been engineered to overcome aminoglycoside-modifying enzymes, the most common aminoglycoside-resistance mechanism in Enterobacteriaceae, and has in vitro activity against extended-spectrum beta-lactamase-producing, aminoglycoside-resistant, and carbapenem-resistant isolates.

Dosage: 15 mg/kg IV every 24 hr for up to 7 days.

Approval was based on the phase 3 evaluating plazomicin in cUTI (EPIC) clinical trial (N=388). Plazomicin was noninferior compared with meropenem for clinical cure and microbiologic eradication at day 5 and test-of-cure at about day 17.

Reference:

• Cloutier DJ, Miller LG, Komirenko AS, et al. Plazomicin Versus Meropenem for the Treatment of Complicated Urinary Tract Infection and Acute Pyelonephritis: Results of the EPIC Study. Presented at the 27th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Vienna, Austria, April 22-25, 2017.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals, 2018 Midyear Review - Medscape - Aug 01, 2018.