japan-112722_640

Lundbeck and Takeda’s depression drug approved in Japan

pharmafile | September 20, 2019 | News story | Medical Communications, Sales and Marketing Japan, Lundbeck, Takeda, major depressive disorder, pharma 

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

Related Content

Intra-Cellular Therapies shares phase 3 results for major depressive disorder therapy

Intra-Cellular Therapies has announced positive topline results from Study 501, which assessed lumateperone 42mg as …

robina-weermeijer-ihfopazzjhm-unsplash_5

MHRA approves Takeda’s Hyqvia for chronic inflammatory demyelinating polyneuropathy treatment

Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing …

Takeda and ImmunoGen collaborate for development and commercialisation of Elahere in Japan

ImmunoGen has announced that it has entered into an exclusive collaboration with Takeda Pharmaceutical Company …

Latest content