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Lundbeck and Takeda's depression drug approved in Japan

Published on 20/09/19 at 09:32am

Takeda and Lundbeck have announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has chosen to authorise their drug Trintellix (vortioxetine) for the treatment of major depressive disorder, described in the companies’ press release as “depression and depressed state”.

This marks the 84th national approval for the drug, which is already marketed in the US, Europe, China, Canada, Australia, South Africa, Mexico, Argentina, and South Korea to name a few.

Phase 3 data submitted in support of the application showed that Trintellix demonstrated a “statistically significant improvement in overall symptoms of depression in adults as compared to placebo”. Furthermore, it was shown that the drug met its primary endpoint of change in total score from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) in eights weeks of administration compared to placebo.

 “I am pleased that individuals suffering from depression in Japan now also have access to this important treatment option,” explained Jacob Tolstrup, Executive Vice President, Commercial Operations at Lundbeck. “Today’s approval of Trintellix, furthermore, represents a new chapter in Lundbeck’s commercial expansion as we will have our own commercial organisation behind the launch of Trintellix in Japan in collaboration with our partner Takeda.”  

Matt Fellows

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