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# Cardio Drug Approval Rates Drop 52% in 30 Years: Analysis
- URL: https://www.fdaweb.com/cardio-drug-approval-rates-drop-52-in-30-years-analysis/
- Published: 2017-09-12T12:00:00.000Z
- Updated: 2026-09-14T22:49:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139596

The relative share of new cardiovascular drugs receiving FDA marketing approval dropped by 52% from the 1980s through 2016, according to a Tufts Center for the Study of Drug Development analysis in its September/October *Impact Report*. The [report](http://csdd.tufts.edu/reports/impact%5Freports?ref=fdaweb.com) (purchase or subscription required) says that although clinical development time for cardiovascular drugs receiving FDA approval increased by 47% from 1999 through 2016, cardiovascular drugs have shorter clinical development times, on average, compared to all other approved drugs (six versus seven years).

According to Tufts, the “development gauntlet seems especially challenging for cardiovascular drugs, and has been exacerbated by, among other factors, rising costs and regulatory uncertainty. The net result is that only 2% of cardiovascular compounds that entered clinical testing in the 2001-07 period eventually obtained marketing approval, approximately one-sixth of the rate for non-cardiovascular compounds. At the same time, investment in other therapeutic areas has been growing.”

The analysis found that about 27 investigational cardiovascular compounds were taken into clinical testing during 1995-2007 for every one that was approved. And the overall approval success rate for cardiovascular compounds was less than one-third that of all non-cardiovascular compounds combined. Also, the Phase 3 to NDA/BLA submission transition rate was 30 percentage points lower for cardiovascular drugs.

Approval success rates for cardiovascular compounds fell from 5.2% for compounds starting clinical testing 1995-2000 to 2.2% during 2001-2007 or a 58% decline. The study says this compares to a decline from 13.9% to 12.9% for non-cardiovascular compounds in the same period.

Mean clinical development time for cardiovascular drug approvals increased by nearly two years (40% more) from 1999-2004 to 2005-2010, and then increased another 7% from 2005-2010 to 2011-2016, according to the report. While average clinical development time was 31% shorter for cardiovascular drugs than for other drug approvals during 1999-2004, clinical development times were similar for 2005-2010 and 2011-2016, the report says.

For 1999-2016 approvals, Tufts found, 38% of cardiovascular drugs received a priority review rating from FDA, versus 50% of non-cardiovascular drugs. More than half of cardiovascular approvals for 2005-2010 received a priority review, but only about one-third had a priority review during the six-year periods before and after.

During 1999-2016, the mean approval phase time for cardiovascular drug approvals was 17.5 months or 22%, longer than the 14.3 months for non-cardiovascular approvals. For drugs with priority review ratings, the researchers found, mean approval phase time during 1999-2016 was 1.2 months longer for cardiovascular drugs than for other drugs, while standard review cardiovascular drugs had a mean approval phase time that was 3.6 months longer.

Finally, the cardiovascular share of new drug approvals in the U.S. declined from 27% in the 1980s to 13% during 2010-2016\. By comparison, the study found, the share of new cancer drug approvals increased substantially since the 1980s, with antineoplastic share of approvals increasing from 5% in the 1980s to 29% during 2010-2016.

The study concludes that the demand for new cardiovascular products is likely to continue, especially as heart disease—the leading cause of death for decades in the U.S.—is projected to account for about 25% of all U.S. deaths. “The question for developers is how well they can surmount the obstacles along the way to approval,” the analysis says.