Takeda Pharmaceutical Co Ltd And H. Lundbeck A/S Announce U.S. Submission Of New Drug Application For Vortioxetine

Takeda Pharmaceutical Co Ltd and H. Lundbeck A/S (Lundbeck) jointly announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational agent vortioxetine (Lu AA21004) for the treatment of major depressive disorder (MDD) in adult patients. Vortioxetine is under investigation as an antidepressant with multimodal activity that is thought to work through a combination of two complementary mechanisms of actions: receptor activity modulation and reuptake inhibition. The NDA includes data from six short-term placebo controlled studies, including one dedicated study in the elderly, which have been conducted in regions throughout the world and support statistically significant efficacy of vortioxetine in a dose range of 5 to 20 mg per day. Efficacy of vortioxetine was also demonstrated in a long-term relapse-prevention study in MDD. The vortioxetine global clinical development program included more than 7,500 individuals exposed to the drug.