FDA's PDAC supports use of Brintellix for treating cognitive dysfunction in adults with MDD

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) today announced that the U.S. Food and Drug Administration’s (FDA) 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). Earlier today, the committee also discussed that cognitive dysfunction in MDD represents an appropriate drug development target.

“Today’s positive recommendation underscores the role of addressing the medical need of patients who experience cognitive dysfunction in depression,” said Emiliangelo Ratti, Senior Vice President, Head of CNS Therapeutic Area Unit, Takeda. “Common cognitive symptoms include difficulty concentrating, indecisiveness and trouble thinking. Many of these symptoms are prevalent during major depressive episodes and can have an impact on depressed patients.”

The Advisory Committee provides the FDA with independent expert advice and recommendations. 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.

“We are pleased with the Advisory Committee's recommendation that we have provided substantial evidence to support a claim of effectiveness of Brintellix for treating certain aspects of cognitive dysfunction in MDD,” said Anders Gersel Pedersen, Executive Vice President, Head of Drug Development at Lundbeck. This positive vote underscores the value of the robust research we’ve conducted on cognitive symptoms, which we’ve pursued knowing that patients need options. We are pleased that this sNDA represents the first regulatory submission to the FDA on this topic and we look forward to working with the Agency as they complete their review.

Depression can be a combination of multiple symptoms, including cognitive dysfunction.i The prevalence of cognitive dysfunction associated with depression is high. 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 acute major depressive episodes and 44 percent of the time during remission.

The Advisory Committee reviewed data from the FOCUS and CONNECT studies, which were specifically designed to assess the effect of Brintellix on certain aspects of cognitive dysfunction in adult patients (18-65 years) with MDD. These two 8-week, randomized, double-blind, placebo-controlled studies of Brintellix 10 and 20 mg/day used a neuropsychological test of cognitive performance (the Digit Symbol Substitution Test or DSST).

The FDA approved Brintellix on September 30, 2013 for the treatment of MDD in adults. Brintellix is furthermore approved in 64 countries (including Europe, Brazil, Canada, Chile, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore and South Africa).