Recently, an analysis completed by the Tufts Center for the Study of Drug Development found that new anti-infective drugs that garnered marketing approved in the United States took 14% less time to undergo clinical trials and obtain regulatory approval, when compared to other drugs that came to market during the same time period (the last two decades).
According to the analysis, clinical and approval phase timelines for anti-infective drugs was 7.1 years, compared to 8.3 years for all other drugs approved by the United States Food and Drug Administration (FDA) from 2000 through 2019.
The analysis, based on a study of 93 anti-infectives that received FDA approval from 2000 – 2019, found that from the first half to the second half of the timeline, mean total phase time (clinical plus approval phase times) for new anti-infective drugs declined by 3 months (3.4%) while that same mean total phase time for all other drugs increased by 6.8 months (7.3%).
“Faster development times for anti-infective drugs is welcomed news, as the need for effective new medicines to treat novel pathogens and antibiotic-resistant infections continues to grow,” said Joseph A. DiMasi, director of economic analysis and research associate professor at Tufts CSDD, principal investigator of the study.
Other findings include the following:
- Mean clinical phase time for anti-infectives was 8.1% shorter compared to all other drugs approved from 2000-2009, and 14.8% shorter from 2010-2019.
- Mean approval phase time for anti-infectives was 15.6% shorter compared to all other drugs approved from 2000-2009, and 23.1% shorter from 2010-2019.
- Mean total phase time was 22% shorter for antivirals when compared to other anti-infectives during 2000-2019.
Additionally, almost three-fourths (74.2%) of anti-infective drug approvals received at least one facilitated regulatory pathway designation by the FDA, compared to just over half (53.9%) for all other drugs approved during 2000-19. Differences were only notable for fast track and priority review programs.