Takeda, Lundbeck announce FDA acceptance of vortioxetine NDA submission

Dec 13 2012

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.