Plazomicin Receives FDA Approval for Complicated UTIs

The US Food and Drug Administration has approved Achaogen, Inc.’s Zemdri (plazomicin) for the treatment of adults with complicated urinary tract infections, including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options.

“The approval of Zemdri marks a significant milestone for Achaogen and we are excited to offer healthcare practitioners a new treatment option for patients with certain serious bacterial infections,” said Blake Wise, Achaogen’s Chief Executive Officer, in a statement.

Plazomicin is active against pathogens including carbapenem-resistant (CRE) and extended spectrum beta-lactamase (ESBL)- producing Enterobacteriaceae, which have been designated by the CDC as urgent and serious public health threats.

“Zemdri is designed to retain its potent activity in the face of certain difficult-to-treat MDR infections, including CRE and ESBL- producing Enterobacteriaceae,” said Wise. “Today's milestone was made possible by our employees, by patients and investigators involved in our clinical trials, and by BARDA, who contributed significant funding for the development of Zemdri. This marks an important step in our commitment to fighting MDR bacteria and we are excited to launch Zemdri, a much needed once-daily antibiotic.”

The application for approval of plazomicin included data from the Evaluating Plazomicin In cUTI (EPIC) trial, which demonstrated non-inferiority to meropenem. The composite cure rates at Day 5 were 88.0% for plazomicin compared to 91.4% for meropenem. At the test-of-cure visit (Day 17 + 2) the composite cure rates were 81.7% for plazomicin and 70.1% for meropenem.

“Bacteria continue to circumvent existing antibiotics, making certain infections notoriously hard to treat and putting some patients at high risk for mortality,” said James A. McKinnell, MD, Assistant Professor of Medicine at the David Geffen School of Medicine and LA Biomed at Harbor-UCLA. “Aminoglycosides are a familiar and very effective class of antibiotics. I look forward to adding plazomicin to my short list of available treatment options and to its potential impact on patient outcomes.”

Plazomicin is administered once daily via an intravenous infusion. It is indicated for patients 18 years of age and older who have limited or no other treatment options for complicated urinary tract infections (cUTI), including pyelonephritis caused by susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Enterobacter cloacae.

The potential indication of plazomicin for the treatment of bloodstream infection (BSI) was not approved. The FDA issued a Complete Response Letter (CRL) stating that there was not enough support for the efficacy of plazomicin in treating BSI. Achaogen intends to meet with the FDA to discuss a resolution to the CRL.