FDA accepts sNDA to review Brintellix clinical trial data for treatment of major depressive disorder

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) announced today the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for review to add clinical data regarding the effect of Brintellix (vortioxetine) 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 U.S. for the treatment of MDD in adults. The FDA is expected to take action on this filing by March 28, 2016.

Depression includes a range of symptoms including cognitive ones.i The cognitive symptoms of depression may go unrecognized by both healthcare providers and patients. Common cognitive complaints include difficulty concentrating, indecisiveness, trouble thinking and forgetfulness.i,ii These symptoms are common and many of them often persist between major depressive episodes.i,ii According to a three-year prospective study of people treated for depression, cognitive symptoms (defined as diminished ability to think or concentrate and/or indecisiveness) were reported 94 percent of the time during major depressive episodes and 44 percent of the time between major depressive episodes (or during periods of partial remission).ii

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

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.iii,iv 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).iii,iv The DSST performance measurement involves executive function, processing speed and attention.iii,iv

"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.

"The rigorous studies we have conducted with Brintellix evaluating the effects on certain aspects of cognitive functioning in patients with MDD are examples of the commitment our companies have to assessing prevalent cognitive symptoms in patients with MDD - in particular, a core set of symptoms that remain problematic for many people with depression," said Staffan Schuberg, President, Lundbeck U.S. "We look forward to contributing to this emerging area of clinical understanding with the hopes of increasing the awareness of the burden of this disorder."

The FDA approved Brintellix on September 30, 2013 for the treatment of MDD in adults.


Takeda Pharmaceutical Company Limited; H. Lundbeck A/S


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