Takeda Pharmaceutical Company Limited and H. Lundbeck A/S have 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). 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."