Achaogen announced that the Food and Drug Administration (FDA) has approved Zemdri (plazomicin) for adults (aged ≥18 years) with complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible microorganism(s): Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae.
Zemdri, an aminoglycoside antibacterial, is a once-daily intravenous (IV) infusion that was designed to resist aminoglycoside-modifying enzymes. It possesses in vitro activity against ESBL-producing, aminoglycoside-resistant, and carbapenem-resistant isolates. Zemdri should be used in cUTI patients who have limited or no alternative treatment options.
The FDA approval was based on data from the randomized controlled EPIC (Evaluating Plazomicin for cUTI) trial which evaluated once-daily Zemdri for the treatment of cUTI, including pyelonephritis. Treatment with Zemdri proved non-inferior to meropenem for the co-primary efficacy endpoints of composite cure (clinical cure and microbiological eradication) in the microbiological modified intent-to-treat (mMITT; N=388) group at day 5 and at test-of-cure (TOC) visit. The composite cure rates at day 5 were 88.0% for Zemdri vs 91.4% for meropenem (difference -3.4%, 95% CI, -10.0 to 3.1). At TOC, the composite cure rates were 81.7% for Zemdri vs 70.1% for meropenem (difference 11.6%, 95% CI, 2.7 to 20.3).
Regarding a second indication for the treatment of bloodstream infections (BSI), the FDA stated in its Complete Response Letter (CRL) that the CARE study did not demonstrate substantial efficacy data to treat BSI.
Zemdri carries a Boxed Warning describing reports of nephrotoxicity, ototoxicity, and neuromuscular blockade, as well as fetal harm if administered during pregnancy.
Zemdri is supplied as a 500mg/10mL strength solution for injection in single-dose, 10mL vials in 10-count cartons. It is expected to be available July 2018.
For more information call (833) 252-6402 or visit Zemdri.com.