The U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) is meeting today to review plazomicin, which was developed for the treatment of adults with complicated urinary tract infections and bloodstream infections.
The Advisory Committee meeting is scheduled for 8:30 a.m. ET. The briefing materials can be found on the FDA website at:
The Prescription Drug User Fee Act date for completion of the FDA's review of the Company's New Drug Application for plazomicin is June 25, 2018.
The Antimicrobial Drugs Advisory Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of infectious diseases and disorders and makes appropriate recommendations to the Commissioner of Food and Drugs.
About Plazomicin and Multi-Drug Resistant (MDR) Gram-Negative Infections
Plazomicin is an aminoglycoside that was developed to treat serious bacterial infections due to Multidrug resistant gram-negative bacteria including carbapenem-resistant Enterobacteriaceae (CRE), and has been evaluated in two Phase 3 clinical trials, EPIC and CARE. MDR gram-negative bacteria are a type of bacteria with resistance to multiple antibiotics. They can cause bacterial infections that pose a serious threat for hospitalized patients. The problem is extensive and growing; the Centers for Disease Control and Prevention (CDC) characterized CRE as "nightmare bacteria" and an immediate public health threat that requires "urgent and aggressive action". Patients with MDR infections often have limited or inadequate therapeutic options leading to high rates of mortality.
Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative antibacterial treatments for MDR gram-negative infections. Achaogen is developing plazomicin, its lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. The Food and Drug Administration has granted plazomicin Breakthrough Therapy designation for the treatment of bloodstream infections caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Achaogen's plazomicin program has been funded in part with federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. The Company's second product candidate C-Scape, an orally-administered beta-lactam/beta-lactamase inhibitor combination, is funded in part with Federal funds from BARDA. Achaogen has other programs in early and late preclinical stages of development focused on MDR gram-negative infections and additional disease areas. All product candidates, including plazomicin, are investigational and have not been approved for commercialization. For more information, please visit www.achaogen.com.
Source: Achaogen, Inc.
Ashley R. Robinson
LifeSci Advisors, LLC
Denise T. Powell
Red House Consulting, LLC
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