Federal regulators have blocked a novel bid by two drug makers to give their pricey — and poorly-selling — antidepressant a boost by marketing it as a treatment for a whole new category of depression symptoms.
The Food and Drug Administration declined to expand approval for the drug, sold as Brintellix, to treat foggy thinking and other cognitive problems that sometimes accompany depression, drug makers Takeda Pharmaceuticals and Lundbeck said on Monday. The rejection was unusual, given that an advisory panel to the FDA had voted 8-2 last month in favor of the drug makers’ application.
The companies said they were “disappointed” but plan to continue conversations with FDA.
Brintellix has been on the market as a treatment for depression for several years, but psychiatrists told STAT that they don’t see a clear difference in how it treated cognitive symptoms relative to its competitors.
Carving out cognitive dysfunction as separate category of symptoms — distinct from emotional symptoms like sadness and apathy — is a fraught task. There’s as yet no consensus about how to diagnose cognitive dysfunction associated with depression, or what to measure in testing potential treatments.