Takeda and Lundbeck will by relieved by news that FDA advisors are backing the effectiveness of their antidepressant Brintellix for treating certain aspects of cognitive dysfunction in adults with Major Depressive Disorder (MDD).
The regulator’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8-2 that the companies had presented enough evidence to back the drug’s expanded approval.
Brintellix (vortioxetine) is currently approved and available in the US for the treatment of MDD in adults, but on the back of data from the FOCUS and CONNECT studies, which show that it can improve certain aspects of cognitive dysfunction, such as processing speed and attention, the firms are seeeking to expand its scope.
The cognitive symptoms of depression may go unrecognised by both healthcare providers and patients, and yet they are extremely common and often persist between major depressive episodes, the firms note. The panel agreed that cognitive dysfunction in MDD represents an appropriate drug development target.
The positive recommendation “underscores the role of addressing the medical need of patients who experience cognitive dysfunction in depression,” said Emiliangelo Ratti, head of Takeda’s CNS Therapeutic Area Unit.
“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”.
Brintellix inhibits serotonin (5-HT) reuptake and is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. Lundbeck says the drug “is considered to be the first and only compound with this combination of pharmacodynamic activity”, but its mechanism is not fully understood.