EU approves Brintellix for Major Depressive Disorder-Lundbeck

The EU has approved Brintellix (vortioxetine), from Lundbeck, for the treatment of adults with Major Depressive Disorder (MDD). Approval is based on studies of several thousand patients who experienced an acute episode of major Depression and who were treated with Brintellix for 6-8 weeks in 12 clinical trials. The treatment was associated with significant improvements in Depression relative to placebo.

The drug was also associated with a halving in the risk of relapse versus placebo in a long-term study. In addition the 12-week REVIVE study demonstrated that Brintellix was superior to Valdoxan (agomelatine) in adults with MDD. The drug was approved for this indication by the FDA in September 2013.