Achaogen's NDA for Plazomicin Accepted for Priority Review

On January 2, 2018, Achaogen announced that the US Food and Drug Administration had accepted their New Drug Application (NDA) for priority review. According to a press release from the company, "In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application. The NDA is supported by data from both the Evaluating Plazomicin In cUTI (EPIC) and Combating Antibiotic-Resistant Enterobacteriaceae (CARE) clinical trials which evaluated the safety and efficacy of plazomicin in patients with serious infections caused by gram-negative pathogens, including extended-spectrum beta-lactamase (ESBL) producing and carbapenem-resistant Enterobacteriaceae (CRE). The FDA granted Breakthrough Therapy designation for plazomicin for the treatment of bloodstream infections (BSI) caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options.”

Plazomicin is a next-generation aminoglycoside with in vitro activity against multidrug-resistant Enterobacteriaceae. Achaogen submitted their NDA back in October 2017.

The 2 important trials that were conducted to ascertain the safety and efficacy of plazomicin were the EPIC study, which assessed if monotherapy with once-daily plazomicin was safer and more effective than thrice-daily meropenem to treat patients with cUTI, including acute pyelonephritis, and the CARE, study, which assessed how safe and effective plazomicin was in comparison with colistin “when used as part of a definitive combination regimen” to treat serious CRE-associated infections.

"Clinical data from the EPIC trial showed a lower clinical relapse rate for plazomicin compared to meropenem in cUTI and a mortality benefit for plazomicin compared to colistin in the CARE trial," Dr. McKinnell told Contagion^®.

"Plazomicin represents a critical option for CRE infections because, unlike other available agents that are based on a penicillin or beta-lactam structure, plazomicin has a completely different mechanism of action. Plazomicin may be the only drug for CRE infected patients with penicillin allergy and for particularly challenging isolates, like NDM CRE that demonstrate resistance to all penicillin or beta-lactam antibiotics," Dr. McKinnell told Contagion^®.