Infectious diseaseSuperbug crisis shows progress in antibiotic development “alarmingly elusive”

Published 8 August 2013

Despite the desperate need for new antibiotics to combat increasingly deadly resistant bacteria, the U.S. Food and Drug Administration (FDA) has approved only one new systemic antibiotic since the Infectious Diseases Society of America (IDSA) launched its 10 x ’20 Initiative in 2010 — and that drug was approved two and a half years ago.The IDSA says that time is running out for meeting the IDSA Goal of ten new antibiotics by 2020.

Despite the desperate need for new antibiotics to combat increasingly deadly resistant bacteria, the U.S. Food and Drug Administration (FDA) has approved only one new systemic antibiotic since the Infectious Diseases Society of America (IDSA) launched its 10 x ’20 Initiativein 2010 — and that drug was approved two and a half years ago.

In a report, published in April in Clinical Infectious Diseases, IDSA identified only seven new drugs in development for the treatment of infections caused by multidrug-resistant gram-negative bacilli (GNB) bacteria. An IDSA release reportsthat GNB, which include the “nightmare bacteria” to which the Centers for Disease Control and Prevention (CDC) alerted the public in its March 2013 Vital Signsreport, represent the most pressing medical need. Importantly, there is no guarantee that any of the drugs currently in development to treat GNB will make it across the finish line to FDA approval and none of them will work against the most resistant bugs we’re worried about today.

“In the past, the 10 x ‘20 goal would have been considered modest, but today the barriers to approval of nine additional antibiotics by 2020 seem insurmountable,” said Henry Chambers, MD, chair of IDSA’s Antimicrobial Resistance Committee (ARC). “Some progress has been made in the development of new antibiotics, but it’s not nearly enough, and we absolutely must accelerate our efforts.”

“We’re losing ground because we are not developing new drugs in pace with superbugs’ ability to develop resistance to them. We’re on the precipice of returning to the dark days before antibiotics enabled safer surgery, chemotherapy and the care of premature infants. We’re all at risk,” said Helen W. Boucher, MD, lead author of the policy paper and a member of IDSA’s Board of Directors and ARC.

Entitled “10 x ‘20 Progress: Development of New Drugs Active against Gram-negative Bacilli: An Update from the Infectious Diseases Society of America,” the paper outlines actions that must be taken to address the synergistic crises of an anemic antibiotic pipeline coupled with an explosion in multi-drug resistant pathogens. A multi-pronged approach is needed, including new economic incentives to encourage antibiotic research and development (R&D); clarification of FDA’s requirements for antibiotic approval; increased research funding; improved infection prevention; and new public health efforts including better data collection and surveillance of drug resistance and use of antibiotics. We also need to encourage “antibiotic stewardship,” which includes measures that health care facilities, providers and even