While the pipeline of new antibiotics has improved over the past six years, momentum in the development of new infection-fighting agents remains inadequate and could take a significant downturn without new incentives, a report released in Clinical Infectious Diseases shows.
The report, an update of progress toward the Infectious Diseases Society of America’s 10 x ’20 initiative to see FDA approval of 10 new systemic antibacterial agents by 2020, follows a 2013 report on the status of the antibacterial drug pipeline.
While the numbers of antibiotics annually approved for marketing in the US has increased following a decline in the previous decade, the authors found, the most recently approved drugs represent modifications to existing classes, rather than innovative approaches. With some momentum propelled by antibiotic incentives enacted in the last few years as well as by increased funding for NIAID and BARDA, the report finds that unmet needs persist, with far too few treatment options available for multidrug resistant infections. At the same time, while larger pharmaceutical companies continue to leave the field, the small companies that are responsible for most of the antibiotic innovation are struggling to stay in business, the authors note.
Highlighting needs for additional incentives to stabilize the antibiotic market and fuel the development of drugs needed to address current and future threats, as well as for improved oversight and stewardship to protect the effectiveness of existing drugs, the authors call for increased regulatory, governmental, industry, and scientific support and collaboration.
Enabling complex surgeries that include organ and bone marrow transplants, as well as cancer chemotherapy and successful care of preterm infants and others with weakened immune systems, effective antibiotics remain critical to benefitting from the advances of modern medicine. The Infectious Diseases Society of America will continue propose legislative, regulatory, and funding solutions to address the inadequate development of new medicines in the face of the growing crisis of infections resistant to existing antibiotics.
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The report is here: The Infectious Diseases Society of America’s 10 × ’20 Initiative (Ten New Systemic Antibacterial Agents FDA-approved by 2020): Is 20 × ’20 a Possibility?