Update to label of Brintellix (vortioxetine) for major depressive disorder filed with FDA- Takeda/Lundbeck

The FDA has accepted a supplemental New Drug Application for review to add clinical data regarding the effect of Brintellix (vortioxetine), from Takeda/Lundbeck, on certain aspects of cognitive function in adults with Major Depressive Disorder (MDD) to the current product label. Brintellix is currently approved and available in the US for the treatment of MDD in adults. The FDA is expected to take action on this filing by March 28, 2016.

The sNDA is primarily based on the FOCUS and CONNECT studies, which were specifically designed to assess the effect of Brintellix on certain aspects of cognitive function in adult patients with MDD utilizing objective measures of cognitive function. These two 8-week, randomized, double-blind, placebo-controlled studies of Brintellix 10 and 20 mg/day used a well-established neuropsychological test (the Digit Symbol Substitution Test or DSST). The DSST performance measurement involves executive function, processing speed and attention.

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.