FDA advisory committee supports sNDA for Brintellix (vortioxetine) in major depressive disorder- Takeda/Lundbeck

Takeda Pharmaceutical and Lundbeck have announced that the FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that the companies presented substantial evidence to support the effectiveness of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD). The committee also discussed that cognitive dysfunction in MDD represents an appropriate drug development target.

The committee's input will be considered by the Agency in its review of the Brintellix sNDA, which was accepted for review in August 2015. The FDA is expected to make a decision by March 28, 2016. The FDA is not bound by the committee's guidance.

Comment: The FDA approved Brintellix on September 30, 2013 for the treatment of MDD in adults. If the sNDA is approved by the FDA, Brintellix would be the first treatment for MDD to include clinical trial data showing an effect on certain aspects of cognitive function in the U.S. label.