According to the new report, only one in 13 investigational diabetes drugs that entered clinical testing from 1995 to 2007 received US marketing approval – in contrast to one in eight of all investigational drugs.
Yet, while diabetes drugs that enter the clinical pipeline are less likely to enter Phase III testing (12.8%, vs. 21.1% for all drugs), once in Phase III, diabetes drugs achieve marginally higher approval rates (60% vs. 56% for all drugs), according to the study.
Joseph A. DiMasi, director of economic analysis and research associate professor at the Tufts Center for the Study of Drug Development, who conducted the study, told us that it was surprising to find that few diabetes drug approvals have been viewed by the FDA as representing “significant gains over existing therapy” in recent years (i.e., had received priority review designations from the FDA).
Specifically, from 1995 to 2015, 15% of new diabetes drugs approved received a priority review designation from the FDA, compared to 50% for non-diabetes endocrine drugs, and 46% for all non-endocrine drugs, according to the report.
“What was also notable were the lower than average success rates for diabetes drugs and that development times for diabetes drugs increased significantly in recent years,” added DiMasi. According to the report, the mean clinical development time for diabetes drugs increased by 1.3 years from 2002-08 to 2009-15.
However, DiMasi explained that both these issues could be related to more stringent regulation, which was enacted in 2008 following concerns over cardiovascular risks associated with new diabetes drug approvals.
Additionally, data indicated that new drug application trial sizes “increased significantly because of the need for more comprehensive cardiovascular safety testing,” DiMasi explained.
“Our results on longer development times and a lower likelihood of regulatory success are consistent with increased regulatory stringency,” he added.