Shots:

• The MHLW’s approval follows P-III study (NCT02389816) assessing Trintellix (10mg/20mg) vs PBO in 493 patients with recurrent depression in Japan which demonstrated improvement in overall symptoms of depression in adults
• The NDA submission also follows other three pivotal studies conducted globally (NCT01255787) and in Japan (NCT01355081- NCT01395147)- submitted on Sept’2018. In 2007- the companies collaborated to co-develop & co-commercialize Trintellix in Japan
• Trintellix is a serotonin reuptake inhibitor- regulating neurotransmission via serotonin- norepinephrine- dopamine- acetylcholine and histamine and is an approved therapy in 83 countries including the US- EU and other countries

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Ref: Takeda | Image: Takeda