Lundbeck, Takeda planning Japanese regulatory submission for vortioxetine

H. Lundbeck A/S (CSE:LUN) and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) plan to submit a regulatory application in Japan this year for Brintellix vortioxetine (Trintellix) to treat major depressive disorder (MDD) after the drug met the primary endpoint in a Japanese Phase III trial in the indication.

The trial enrolled about 490 patients with recurrent MDD and evaluated once-daily oral Brintellix compared with placebo on the primary endpoint of the change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at week eight. The companies did not disclose detailed data...