Development of Antibiotics Increases but Remains Insufficient
FEBRUARY 07, 2019
Signiﬁcant patient morbidity and mortality has resulted from infections caused by antibiotic-resistant bacteria, such as carbapenem-resistant Enterobacteriaceae.
Although novel antibiotics has improved in the pipeline over the past 6 years, inadequacy behind the momentum in the development of new infection-fighting agents still remains. This inadequacy also has the potential to take a significant downturn in the absence of new incentives.
Due to the increased frequency of these infections, The Infectious Diseases Society of America (IDSA) has and continues to propose legislative, regulatory, and funding solutions in order to address this growing crisis.
Their efforts are largely reflected in the IDSA’s 10 x '20 initiative, which aims at obtaining US Food and Drug Administration (FDA) approval of 10 new systemic antibacterial agents by 2020. This initiative trails a 2013 report on the status of the antibacterial drug pipeline.
As a part of its efforts, the IDSA reported the status of development and approval of systemic antibiotics in the United States as of late 2018.
In order to identify new systemically acting orally and/or intravenously administered antibiotic drug candidates in the development pipeline—in addition to agents approved by FDA since 2012—the IDSA conducted a review of the published literature and on-line clinical trials registry at www.clinicaltrials.gov.
The number of new antibiotics approved annually for marketing in the US has reversed its previous decline since the society’s 2013 pipeline status report. Investigators noted that this may be due to novel financial incentives and an increased regulatory flexibility.
Rather than new chemical classes, the majority of recently approved agents have been modifications of existing chemical classes of antibiotics, though, despite the survey demonstrating strides in the development of new antibacterial drugs that target infections caused by resistant bacterial pathogens.
As a consequence, smaller companies endure financial difficulties while larger pharmaceutical companies continue to leave the field.
From their report, investigators concluded that the apex of antibiotic drug development could be marked for years to come if 20 x ’20 is achieved due to efforts embarked upon in decades past.
Durable solutions to the clinical, regulatory, and economic problems posed by bacterial multidrug resistance will not be obtainable without increased regulatory, governmental, industry, and scientific support and collaboration.
Consequently, investigators noted that the need for additional incentives in order to stabilize the antibiotic market and supply the drug development needed to combat current and future threats in addition to improving oversight and stewardship to protect the effectiveness of existing drugs are further highlighted by this review. Investigators called for an increase in regulatory, governmental, industry, and scientific support and collaboration.
Providing effective antibiotics for complex surgeries that include organ and bone marrow transplants, as well as for the care of patients undergoing cancer chemotherapy and successful preterm infant care and others with weakened immune systems, are critical benefits that are needed to contribute to the advances of modern medicine.
Efforts that include proposing legislative, regulatory, and funding solutions to address the inadequate development of new medicines in light of the growing crisis of infections resistant to existing antibiotics will continue under the IDSA.
The study, titled, “The Infectious Diseases Society of America’s 10 × ’20 Initiative (Ten New Systemic Antibacterial Agents FDA-approved by 2020): Is 20 × ’20 a Possibility?” was published online in Clinical Infectious Diseases.