Posted by Michael Wonder on 24 May 2017
Plazomicin granted FDA breakthrough therapy designation
23 May 2017 - Breakthrough therapy designation supports the potential of plazomicin as a substantial improvement over existing therapies
Achaogen today announced that the U.S. FDA granted breakthrough therapy designation for plazomicin, Achaogen's lead product candidate being developed for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae.
The Phase 3 CARE trial data provided clinical evidence to support the 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.
