H. Lundbeck, an international pharmaceutical company, has submitted a marketing authorization application (MAA) to the EMA 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 10 large, placebo-controlled clinical short and long term studies in major depression using dosages from 5mg to 20mg of vortioxetine. This data package includes studies in relapse prevention and in elderly patients with major depression.
More than 5,000 individuals have been exposed to vortioxetine worldwide, including the U.S., across the entire clinical trial program. Vvortioxetine was generally well-tolerated, with the most common adverse event being nausea.
Lundbeck plans to submit a new drug submission (NDS) to Health Canada for vortioxetine during the second half of this year as well. Separately, Lundbeck and Takeda, its partner in the U.S. and Japan, plan to submit am NDA to the FDA during the fourth quarter of 2012 and in Japan during 2013.