Background Analysis: US FDA Advisory Committee to Review New Cognitive Function Claim for Brintellix – FEB 3, 2016 (PDAC)

The US FDA has scheduled a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting for Wednesday, February 3, 2016.

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). Brintellix was discovered by Lundbeck A/S and jointly developed by Lundbeck and Takeda. Takeda holds the NDA for the US market.

See the SAC Tracker report