Lundbeck files for EMA approval of vortioxetine for depression

Friday, September 21, 2012 01:34 PM

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. 

Share:          
CWWeekly

May 4

Walgreens leverages its 100 million customer database in patient recruitment deal with five big pharma companies

Synchrogenix partners with CISCRP on transparency, developing lay language trial summaries for participants

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

Already a subscriber?
Log in to your digital subscription.

Purchase the May issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

Already a subscriber?
Log in to your digital subscription.

Purchase the April issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs