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FDA Accepts Takeda and Lundbeck's Submission of the New Drug Application for Vortioxetine for the Treatment of Major Depressive Disorder
Date:12/12/2012

DEERFIELD, Ill., Dec. 12, 2012 /PRNewswire/ -- Takeda Global Research & Development Center, Inc., (Takeda) and H. Lundbeck A/S (Lundbeck) jointly announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing their submission of a New Drug Application (NDA) for vortioxetine for the treatment of major depressive disorder (MDD) in adult patients. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is targeted for completion by October 2, 2013. Additionally, Takeda and Lundbeck announced Brintellix™ (pronounced "Brin´-tel-ix") as the proposed global trade name for vortioxetine, pending final acceptance by the FDA and other regulatory agencies.

The NDA includes positive data from six short-term studies, one long-term maintenance study, and more than 7,500 total patients aged 18 to 88 years old. MDD, often referred to as major depression, is a common, debilitating illness affecting around 15 million Americans and 121 million people worldwide. Depression was the third leading contributor to the global burden of disease in 2004 and is projected to be the leading contributor to the worldwide burden of disease by 2030.

About vortioxetine (Lu AA21004)
Vortioxetine is under investigation as an antidepressant with multimodal activity that is thought to work through a combination of two mechanisms of action: receptor activity modulations and reuptake inhibition.

In vitro studies indicate that vortioxetine is a 5-HT3 and 5-HT7, and 5-HT1D receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the serotonin (5-HT) transporter (SERT). In vivo non-clinical studies have demonstrated that vortioxetine enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylchol
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SOURCE Takeda Global Research & Development Center, Inc.; H. Lundbeck A/S
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