US FDA okays Lundbeck, Takeda joint sNDA for antidepressant Brintellix

11 August 2015

Danish CNS drug specialist Lundbeck (LUN: CO) on Tuesday with Japanese drug major Takeda Pharmaceutical (TYO: 4502) said the US Food and Drug Administration has accepted a supplemental New Drug Application for antidepressant Brintellix (vortioxetine).

The trial will assess the effect of Brintellix on certain aspects of cognitive function in adult patients with MDD utilizing objective measures of cognitive function. The company in a joint statement with Takeda Pharmaceutical said the FDA is expected to take action on this filing by end March 2016.

John Zajecka, Associate Professor of Psychiatry, Rush University Medical Center, in Chicago, said: "Cognitive symptoms are often present in patients suffering from MDD and reducing these symptoms can be challenging. Many patients continue to experience certain cognitive and other symptoms even after improvement in their MDD."

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