Results Wire: US FDA Advisory Committee Discusses Assessment of Cognitive Function in Major Depressive Disorder and Supports New Cognitive Function Claim for Brintellix – FEB 3, 2016 (PDAC)

On Wednesday, February 3, 2016 the Psychopharmacologic Drugs Advisory Committee (PDAC) considered the clinical presentation and assessment of cognitive dysfunction in major depression (MDD). The Committee supported, by a vote of 8-Yes to 2-No, with no abstentions, a new claim for the treatment of cognitive dysfunction in MDD for Brintellix (vortioxetine), based on the data that was submitted in a supplemental New Drug Application (sNDA) by Takeda Development Center Americas, Inc. (Takeda).

See the SAC Tracker report