FDA advisory panel supports the effectiveness of Brintellix in added indication

The US Food and Drug Administration's 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, said the drug’s sponsor, Danish CNS specialist Lundbeck (LUN: CO) and Japan’s Takeda Pharmaceutical (TYO: 4502).

"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, adding: "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."