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
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.
GH, et al. The Infectious Diseases Society of America’s 10 × ’20 Initiative
(Ten New Systemic Antibacterial Agents FDA-approved by 2020): Is 20 × ’20 a
Possibility? Clinical Infectious Diseases.
Published 1 February 2019.