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Despite ‘Superbug’ Crisis, Progress in Antibiotic Development Remains Elusive, Study Finds

Only seven drugs in antibiotic pipeline (Apr. 18)

The Infectious Diseases Society of America (IDSA) reports that the FDA has approved only one new systemic antibiotic since the IDSA launched its “10 x ’20” initiative in 2010.

The IDSA initiative is a global effort to foster the development of 10 innovative antibiotics by 2020.

In a new study, published online in Clinical Infectious Diseases, the IDSA identified only seven new drugs in development for the treatment of infections caused by multidrug-resistant gram-negative bacilli (GNB). GNB, which include the “nightmare bacteria” described by the Centers for Disease Control and Prevention (CDC) in its March 2013 Vital Signs report, represent the most pressing medical need. Importantly, there is no guarantee that any of the drugs currently in development to treat GNB will receive FDA approval, and none of them will work against the most resistant bugs, the authors say.

“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,” warned lead author Helen W. Boucher, MD.

The new paper outlines actions that must be taken to address the “synergistic crises” of an anemic antibiotic pipeline coupled with an explosion in multidrug-resistant pathogens. According to the authors, a multi-pronged approach is needed, including new economic incentives to encourage antibiotic research and development (R&D); clarification of the FDA’s requirements for antibiotic approval; increased research funding; improved infection prevention; and new public health efforts, including better data collection and better surveillance of drug resistance and antibiotic usage.

“Antibiotic stewardship” also needs to be encouraged, the authors say. This includes measures that health care facilities, providers, and even patients can take to preserve the effectiveness of antibiotics by limiting their inappropriate use.

According to the report, the number of pharmaceutical companies investing in antibiotic R&D has plummeted. Pharma companies typically put R&D resources into the development of drugs for chronic diseases — including those to treat high cholesterol, diabetes, and cancer — which provide significant financial rewards, partly because they are intended to be taken for long periods, the authors say. Only four large multinational companies remain in antibiotic R&D. One of these, AstraZeneca (which has two of the seven drugs in development), recently announced that it plans to reduce its future investments in antibiotics.

Source: IDSA; April 18, 2013.

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