Takeda/Lundbeck submit joint vortioxetine NDA

Takeda and Lundbeck have made a joint NDA submission to the FDA for vortioxetine (Lu AA21004) for the treatment of major depressive disorder (MDD) in adult patients.

Vortioxetine is under investigation as an antidepressant with multi-modal activity that is thought to work through a combination of two complementary mechanisms of action: receptor activity modulation and reuptake inhibition. The NDA includes data from six short-term, placebo-controlled studies, including one dedicated trial in the elderly, that have been conducted in regions throughout the world and support statistically significant efficacy of vortioxetine in a dose range of 5 to 20mg/day. Efficacy of the drug was also demonstrated in a long-term relapse-prevention study in MDD. The global clinical development programme included more than 7,500 individuals exposed to the vortioxetine.

In September 2007, Lundbeck and Takeda formed a strategic alliance for the exclusive co-development and co-commercialisation in the US and Japan of several compounds in Lundbeck's pipeline for mood and anxiety disorders. The partnership initially focuses on co-development and co-commercialisation of the two most advanced compounds in Lundbeck's pipeline for mood and anxiety disorders, vortioxetine and tedatioxetine (Lu AA24530). If approved, the companies plan to co-promote the products in the US and Japan. Acceptance by the FDA of the NDA filing would trigger a milestone payment from Takeda to Lundbeck.