The Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee has voted in favor of plazomicin (Achaogen) for the treatment of adults with complicated urinary tract infections (cUTI).
The Committee voted unanimously (15-0) that substantial evidence on the safety and efficacy of plazomicin was presented for the treatment of cUTI but voted against its use (4-11) for the treatment of bloodstream infections in patients with limited or no treatment options.
Plazomicin, a new aminoglycoside antibacterial, was evaluated in two Phase 3 trials, EPIC and CARE. In EPIC, the objective of non-inferiority vs meropenem was met and superiority was achieved (primary efficacy endpoint for the European Medicines Agency) among patients with cUTI and acute pyelonephritis. In CARE, a decreased rate of mortality or serious disease-related complications was observed with plazomicin vs colistin among patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE).
While the FDA is not bound to the Committee’s vote, the input is taken into consideration when reviewing marketing applications. The Prescription Drug User Fee Act (PDUFA) date has been set for June 25, 2018.
For more information call (650) 800-3636 or visit Achaogen.com.