The US Food and Drug Administration has turned down an application to include new clinical data in the label of Lundbeck/Takeda’s Brintellix supporting its use to treat the cognitive symptoms of major depressive disorder (MDD).

The decision will come as a major disappointment, particularly as back in February FDA advisors backed the effectiveness of the antidepressant for treating certain aspects of cognitive dysfunction in MDD patients; the Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8-2 that the companies had presented enough evidence to support the drug’s expanded approval.

However, despite the setback, the companies said they were pleased that the FDA “recognised the importance of cognitive dysfunction in MDD and view it as a legitimate target for drug development”, and “look forward to reviewing the contents of the [complete response letter] with the FDA to determine the appropriate path forward”. 

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 hoping 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 groups note.