23 June 2017 - Lundbeck and Takeda today announced that after providing additional analysis, the U.S. FDA has issued a complete response letter regarding the supplemental new drug application to include new data in the clinical trials section of the U.S. prescribing information of Trintellix (vortioxetine) for treating aspects of cognitive dysfunction in adults with major depressive disorder (MDD).

Takeda and Lundbeck are disappointed, but we believe in the strength of the data and plan to continue discussions with the FDA on potential paths forward. The companies remain committed to the depression community and Trintellix as a treatment option for adult patients living with depression, including those who suffer from cognitive dysfunction as part of this disease.

Read Lundbeck press release