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. This 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.
« Pharmaceutical sponsor and investor disengagement continues to worsen, such that the prognosis for a sustainable antibiotic R&D infrastructure will be bleak in the absence of further economic incentives for antibiotic development. In the meantime, clinicians must protect currently available antibacterial drugs through robust antibiotic stewardship and infection prevention.» 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.
(The Infectious Diseases Society of America’s 10 × ’20 Initiative (Ten New Systemic Antibacterial Agents FDA-approved by 2020): Is 20 × ’20 a Possibility?