Briefs: Takeda and Lundbeck file vortioxetine NDA; Merck Serono spin-out

Japan’s biggest drugmaker Takeda Pharmaceutical (TYO: 4502) and partner Danish CNS specialist Lundbeck (LUND: DC) have submitted a New Drug Application to the US Food and Drug Administration 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 5mg to 20mg 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.