In the USA, cardio drug approval rate falls as development time rises

Although the rate at which investigational drugs received marketing approval in the USA has declined in recent years, the cardiovascular approval rate trailed other drug approvals as a whole, while the time needed to develop cardiovascular drugs rose, according to a recently completed study conducted by the Tufts Center for the Study of Drug Development.

Approval success rates for cardiovascular compounds fell from about 5.2% for compounds that began clinical testing during 1995-00, to about 2.2% for those that started trials during 2001-07, a 58% decline, according to the study. That compares to a decline from 13.9% to 12.9% for non-cardiovascular compounds.

During the same period, mean clinical development time for cardiovascular drug approvals lengthened nearly two years from 1999-04 to 2005-10, and increased another 7% from 2005-10 to 2011-16.