TRINTELLIX® (vortioxetine) Prescribing Information Now Includes New Data Showing Improvement in Processing Speed, an Important Aspect of Cognitive Function in Acute Major Depressive Disorder (MDD)
Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX® (vortioxetine). TRINTELLIX is the first FDA-approved treatment for MDD where the U.S. labelling now includes data from the largest replicated clinical studies on an important aspect of cognitive function in acute major depressive disorder (MDD, depression). The FOCUS and CONNECT studies showed TRINTELLIX had a positive effect on processing speed, an important aspect of cognitive function that may be impaired in adult patients with acute MDD. For more information, see press release at https://www.takeda.com/en-us/newsroom/news-releases/2018/trintellix-cognition-snda-approval/.