Brintellix sNDA Accepted for Labeling Update on Cognitive Effects
Takeda and Lundbeck announced that the Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data to the current product label regarding the effect of Brintellix (vortioxetine) on certain aspects of cognitive function in adults with major depressive disorder (MDD). Common cognitive complaints associated with depression include difficulty concentrating, indecisiveness, trouble thinking, and forgetfulness.
The sNDA is primarily based on results from the FOCUS and CONNECT trials, two eight-week, randomized, double-blind, placebo-controlled studies designed to assess the effect of Brintellix on certain aspects of cognitive function in adult patients with MDD utilizing objective measures of cognitive function. Both trials used a well-established neuropsychological test (Digit Symbol Substitution Test) with performance measurement involving executive function, processing speed, and attention.
“If 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. We look forward to working with the Agency as it considers this important need for patients with MDD,” said Charlie Baum, M.D., Vice President, U.S. Medical Affairs, Takeda.
Brintellix is currently approved and available for the treatment of MDD in adults.
For more information call (877) 825–3327 or visit Takeda.com.