Achaogen Announces FDA Advisory Committee Voted Unanimously in Favor of Plazomicin for Treatment of Adults with Complicated Urinary Tract Infections

Without effective antibiotic therapy, procedures that are currently routine and life-saving such as arterial stents, cancer chemotherapy, joint/organ transplants will become life-threatening or impossible.

Today Achaogen presented the FDA Antimicrobial Drugs Advisory Committee with 'substantial evidence of safety and efficacy' of plazomicin for blood stream infections, as required under the Limited Population Antibacterial Drug (LPAD) Approval Mechanism. Despite these data, the AdCom voted 4-11 against approval for this indication. The committee saw the future and flinched, choosing the status quo, over being part of history. How big does the problem of multi-drug resistant bacteria have to get before they wake to new realities of antibiotic development?