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Thursday 31 July 2014
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Lundbeck files for regulatory approval of vortioxetine

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H. Lundbeck A/S (Lundbeck) today 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).
"I am very pleased that we now have filed vortioxetine in Europe as many people suffering from major depression still struggle to find an effective treatment," says Executive Vice President Anders Gersel Pedersen, Head of Research & Development at Lundbeck, and continues: "I am confident that the efficacy and safety data available will support a successful MAA submission for vortioxetine in major depression and we are currently working with our partner, Takeda, to file the application in the US later in the year and in Japan next year."
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.
Across the programme vortioxetine was generally well-tolerated. The most common adverse event (AE) observed in patients receiving vortioxetine was nausea.
More than 5,000 individuals have been exposed to vortioxetine worldwide, including the US, across the entire clinical trial programme. Statistically significant results were established in major depression on all doses from 5 to 20mg in these studies.
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 US and Japan, plan to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) during the fourth quarter of 2012 and in Japan during 2013. 
Lundbeck plans to present further efficacy and safety data from its pivotal clinical programme at the 166th APA Annual Meeting in San Francisco, USA, 18-22 May 2013.
Lundbeck is committed to further investigate the long-term efficacy and tolerability of vortioxetine as well as its effects on cognitive symptoms (expressed as difficulty concentrating, forgetfulness and inability to make decisions) associated with depression. Vortioxetine's potential effect on cognitive symptoms was recently shown in a study in elderly patients suffering from major depression, which was presented in May 2012 at the APA Annual Meeting in Philadelphia(1) (Poster no. 8-44) and published in the journal International Clinical Psychopharmacology(2). 
About vortioxetine (Lu AA21004)
Vortioxetine is under investigation as a multimodal antidepressant that is thought to work through a combination of two mechanisms of action: receptor activity modulation and reuptake inhibition. In vitro studies indicate that vortioxetine is a 5-HT3 and 5-HT7 receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the serotonin transporter (SERT). In vivo non-clinical studies have demonstrated that vortioxetine enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain.
The multimodal activity profile of vortioxetine may translate into therapeutic benefits in depression that current therapies do not sufficiently address.
References
  1. Olsen et al: "Efficacy and Safety of Lu AA21004 in a Randomised, Double-Blind, Placebo-controlled, Active-referenced, Fixed-dose Study in Elderly Depressed Patients"; Poster NR8-44, APA2012
  2. Cornelius Katona et al: "A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder"; International Clinical Psychopharmacology; May 2012

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