Antibiotics: Development Progresses Slowly

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Pharmaceutical research might lose the race of developing new antibiotics against multiresistent "superbugs" until 2020; © Vedran Vukoja

Despite the desperate need for new antibiotics to combat increasingly deadly resistant bacteria, the U.S. Food and Drug Administration (FDA) have approved only one new systemic antibiotic since 2010. That drug was approved two and a half years ago.

In a new report, the Infectious Diseases Society of America (IDSA) identified only seven new drugs in development for the treatment of infections caused by multidrug-resistant gram-negative bacilli (GNB) bacteria. GNB 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 are 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 medical doctors Henry Chambers, chair of IDSA's Antimicrobial Resistance Committee (ARC). "Some progress has been made in the development of new antibiotics, but it is 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 are on the precipice of returning to the dark days before antibiotics enabled safer surgery, chemotherapy and the care of premature infants. We are all at risk," said medical doctor Helen W. Boucher, 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 patients can take to preserve the life-saving power of antibiotics by limiting their inappropriate use.

"IDSA is committed to ensuring proper use of currently-available antibiotics to make certain we can continue to count on them. But that is not enough. Simply put, the antibiotic pipeline is on life support and novel solutions are required to resuscitate it – now," said IDSA President David A. Relman. "In the past year, the heads of Center of Disease Control and the World Health Organization, along with the United Kingdom's chief medical officer, have all sounded the alarm about rising rates of antibiotic resistance. The lack of new antibiotics to treat these potentially life-threatening infections signals the end of modern medicine as we know it."; Source: Infectious Diseases Society of America