CHMP recommends Brintellix (Lundbeck/Takeda) for Depression

H. Lundbeck A/S (Lundbeck) has announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted on 25 October 2013, a positive opinion and recommended marketing authorisation of Brintellix (vortioxetine) for the treatment of adults with Major Depressive Episodes, commonly referred to as Depression.

Brintellix has been studied in a comprehensive global clinical development program that included more than 7,000 patients. Close to 4,000 patients were treated with Brintellix in 12 short-term (6 to 8 weeks), placebo-controlled studies of Major Depressive Disorder. In 9 of the 12 studies, Brintellix showed statistically significant and clinically relevant effects on depression relative to placebo; one of these studies was a dedicated study in the elderly. In addition, significant effect was observed in the proportions of responders and remitters and in the improvement in the Clinical Global Impression � Global Improvement (CGI-I) score. The efficacy of Brintellix increased with higher doses.

The efficacy of Brintellix was demonstrated in patients with Major Depression in a 12-week head-to-head study versus the most recently approved antidepressant in the EU, agomelatine. Brintellix was significantly superior to agomelatine as measured by improvement in the MADRS total score and by the proportion of remitters and improvement in the CGI-I.