Briefing Summary: US FDA Posts Advisory Committee Materials for Proposed New Cognitive Function Claim for Brintellix – FEB 3, 2016 (PDAC)

The US FDA has posted details, including company and FDA Briefing Materials, for the Wednesday, February 3, 2016 Psychopharmacologic Drugs Advisory Committee (PDAC) meeting. During the morning session, the Committee will consider the clinical presentation and assessment of cognitive dysfunction in major depression (MDD). In the FDA’s announcement of the meeting, the Agency says “This is an evolving concept and experts in the field have not yet reached consensus as to whether cognitive dysfunction in MDD is a distinct entity.”

During the afternoon session, the Committee will discuss supplemental new drug application, sNDA 204447/006, for the effectiveness of vortioxetine (trade name Brintellix) for the treatment of cognitive dysfunction in MDD, submitted by Takeda Development Center Americas, Inc. (Takeda).

See the SAC Tracker report