Lundbeck files vortioxetine at EMA for Major Depressive Episodes

Lundbeck A/S has announced the submission to the European Medicines Agency (EMA) of a marketing authorisation application (MAA) for the approval of the investigational multimodal antidepressant vortioxetine (Lu AA21004), and the dossier has been accepted for review. Vortioxetine belongs to a new generation of antidepressants that has been developed for the treatment of patients with major depressive episodes (MDE).The data package supporting the file is substantial, consisting of ten large, placebo-controlled clinical short and long term studies in major depression using dosages from 5 to 20 mg of vortioxetine. This data package includes studies in relapse prevention and in elderly patients with major depression, both of which were presented at the 165th Annual Psychiatric Association (APA) Annual Meeting in May 2012.