26 October 2017 - Investigational drug has potential to treat certain multi-drug resistant gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae.

Achaogen today announced the submission of a new drug application to the U.S. FDA for plazomicin, seeking approval to treat complicated urinary tract infections, including pyelonephritis and bloodstream infections due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options. The company also intends to submit an application for registration in the European Union in 2018.

The application includes data from both the EPIC and CARE clinical trials which evaluated the safety and efficacy of plazomicin in patients with serious infections caused by gram-negative pathogens, including carbapenem-resistant Enterobacteriaceae. The FDA has granted breakthrough therapy designation for plazomicin for the treatment of bloodstream infections caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. The FDA has also granted fast track designation for the development and regulatory review of plazomicin to treat serious and life- threatening CRE infections. Plazomicin has received qualified infectious disease product designation from the FDA with the objective of providing certain incentives for the development of new antibiotics, including priority review and an additional five years of market exclusivity.

Read Achaogen press release