EMA Finds Efficacy, Safety Concerns Hinder Approvals for CNS Therapies

More than a third of the applications the EMA received for central nervous system candidates raised concerns about efficacy that hindered approvals, an analysis shows.

An EMA analysis of 103 applications submitted for CNS candidates from 1995 to 2014 showed that effectiveness and safety issues have posed major hurdles to the development and approval of treatments for CNS disorders.

Withdrawal rates for CNS candidates have long outpaced those seen among other therapeutic classes because of the distinct challenges to the clinical development of these drugs, according to the report. The EMA conducted the analysis to improve the understanding of these roadblocks.