Diabetes Drugs Riskiest to Develop: Tufts Study

One in 13 investigational diabetes drugs receive FDA marketing approval, compared to one in eight of all drugs, making diabetes drugs the riskiest drugs to develop, according to a Tufts Center for the Study of Drug Development Impact Report analysis (subscription required). The analysis finds that investment in drug development focusing on diabetes and its related conditions continues to grow as demand for new therapies follows continued growth in diagnoses.

The 61 diabetes and non-diabetes endocrine products approved by FDA between 1995 and 2015 accounted for 10% of all FDA new therapeutic drug approvals in that time period, the report says.

Although diabetes drugs that enter the clinical pipeline are less likely than all drugs to go into Phase 3 testing, the researchers say, once in Phase 3, diabetes drug have slightly higher approval rates.

The report shows that 44% of U.S.-approved new endocrine drugs in 1995-2015 were for diabetes and related conditions. Of 27 new diabetes drug approvals, 26 were approved as hypoglycemic agents indicated for Type 2 diabetes, and one was to treat a diabetes-related condition. Seven of the compounds approved for Type 2 diabetes were also approved for Type 1.

Diabetes first-in-class drug approvals represented 29.6% of all approvals, while non-diabetes first-in-class endocrine approvals were 47.1%. None of the diabetes approvals received an orphan drug designation, while half of the non-diabetes endocrine drug approvals were orphan drugs. And only 14.8% of the diabetes drugs received a priority review from FDA, compared to about 50% of all other drugs.

The report shows that after a decline in 2002-2008, mean clinical development time for diabetes drugs increased. Mean clinical development time was 6.4 years for diabetes drugs, 7.5 years for non-diabetes endocrine drugs, and 6.7 years for non-endocrine drugs during 1995-2015, it says.

Average regulatory review times for diabetes drugs have increased substantially since 1995-2001, the researchers say. For the period 1995-2015, mean regulatory approval phase time for diabetes drugs was 15.7 months. Mean regulatory review time for diabetes drug approvals with an FDA standard rating was 13.8 months in 1995-2001. For the full study period, mean regulatory approval phase time was 12.9 months for non-diabetes drugs and 15.7 months for non-endocrine drugs. And over the full study period, mean regulatory review time decreased for non-diabetes endocrine drugs and non-endocrine drugs.

Median clinical development time for diabetes drugs declined about 7% from 1995-2001 and then increased about 28% from 2002-2008 to 2009-2015. The median approval phase time trend for diabetes approvals decreased by 1.9 months for 2002-2008, but then increased by 3.9 months (about 39%) from 2002-2008 to 2009-2015.

Finally, the likelihood that a diabetes drug entering clinical testing would transition to Phase 3 testing was 12.8% versus 21.1% for all drugs. Some 51.3% of diabetes drugs moved from Phase 1 to Phase 2 (59.5% for all drugs) and 25% went from Phase 2 to Phase 3 (35.5% for all drugs).