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news.The US Food and Drug Administration (FDA) has declined to add improved cognitive functions to Brintellix, an antidepressant used to treat major depressive disorder (MDD).
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The agency issued a complete response letter (CRL) to Lundbeck and its Japanese partner Takeda Pharmaceutical declining to expand the drug’s approval to treat various aspects of cognitive dysfunction in adults with MDD.
Brintellix drug is already approved in the US for MDD. The CRL does not apply to the use of Brintellix in MDD.
The agency’s latest decision will come as a major disappointment with the response given that the FDA’s Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8-2 stating the companies had presented enough data to support the drug’s expanded approval.
However, despite the setback, the companies said they were pleased that the FDA recognized the importance of cognitive dysfunction in MDD and view it as a legitimate target for drug development.
The companies noted that they look forward to review the contents of the letter with the FDA to identify the correct path forward.
Brintellix (vortioxetine) is an inhibitor of serotonin (5-HT) reuptake and that is believed to be a mechanism of its action.
It 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 researchers in Copenhagen, Denmark, discovered Brintellix, which is available as 5 mg, 10 mg and 20 mg tablets in the US.
Lundbeck and Takeda jointly carried out the clinical trial program in the US. Takeda holds the new drug application for the US market.