Takeda and Lundbeck’s Trintellix approved in Japan for depression

Takeda has announced that its drug Trintellix (vortioxetine) has been approved by the Japanese Ministry of Health, Labour and Welfare for the treatment of depression and depressed state. Danish company Lundbeck discovered Trintellix, but since 2017 Lundbeck and Takeda have been collaborating on the development of the drug in Japan. The two companies extended the agreement in 2018 to include co-commercialisation of the drug in Japan following its approval. This approval was based upon a randomised, placebo-controlled, double-blind Phase III trial of 493 adult patients in Japan with recurrent depression. In the study, Trintellix demonstrated statistical significant improvement in overall symptoms of depression in adults, compared to placebo. This was the primary endpoint after week eight of administration and as measured by the Montgomery-Åsberg Depression Rating Scale. These results were supported by three other studies: one global and two carried out in Japan. Takeda Development Centre Japan head Naoyoshi Hirota said: “Major depressive disorder (MDD) remains a serious and complicated disease and I firmly believe that Trintellix will be an important new treatment option for patients in Japan, and health care professionals.”