Lundbeck and Takeda granted approval of Trintellix in Japan

20 September 2019

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Trintellix (vortioxetine) for the treatment of depression and depressed state, according to the drug’s developers, Danish CNS specialist Lundbeck (LUND: CO) and its partner Japan’s Takeda Pharmaceuticals (TYO: 4502).

News of the approval pushed Lundbeck’s shares up 2.7% to 241.80 Danish kroner by midday, while Takeda closed up 1.1% at 3,798 yen today. Trintellix generated first-half 2019 sales of 1,299 million kroner ($148.6 million for Lundbeck.

The NDA filing submitted to the MHLW in September 2018 included data from a pivotal Phase III trial (NCT02389816), which demonstrated statistically significant improvement in overall symptoms of depression in adults as compared to placebo. The regulatory submission also featured data from three other pivotal studies conducted globally (NCT01255787) and in Japan (NCT01355081, NCT01395147).

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