FDA rejects call for label change for depression drug Brintellix
Lundbeck and Takeda will not be able to include data on treating certain aspects of cognitive dysfunction on the label of their Brintellix (vortioxetine) depression drug in the US, following a rejection by the regulator.
Brintellix was approved in major depressive disorder (MDD) in 2013, and the companies had applied to include the new data in the clinical trials section of the US label.
But the US Food and Drug Administration rejected the new application in a complete response letter, which does not apply to the drug's already approved use.
The companies said they were disappointed with the response given that advisers on the FDA's Psychopharmacologic Drugs Advisory Committee voted eight to two that the companies had evidence to support effectiveness of Brintellix for some aspects of cognitive dysfunction in adults with MDD.
But the companies added they were pleased the FDA recognised cognitive dysfunction in MDD as a legitimate target for drug development.
Takeda and Lundbeck said they will review contents of the letter with the FDA to determine the appropriate path forward.
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