Posted by Michael Wonder on 13 Nov 2017
Nearly half of recent EU approvals based on a single pivotal study
10 November 2017 - A recent study found that 45% of marketing authorizations granted in the EU from 2012 to 2016 were based on evidence from a single pivotal trial.
The authors of the study, Anne Vinther Morant and Henrik Tang Vestergaard, both employees of Danish drugmaker Lundbeck, say they found the figure to be "surprisingly high," but in line with findings from a recent study of US FDA approvals from 2005-2012.
Despite the high overall figure, the authors found that approvals based on a single pivotal study were mostly limited to life threatening conditions and areas of high unmet need, such as cancer or rare diseases.
