Label Addition for Brintellix Under FDA Review

AUGUST 12, 2015
Krystle Vermes
The FDA is considering a label change for Lundbeck and Takeda’s vortioxetine (Brintellix) to describe the drug’s effect on certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD).

Brintellix is currently approved and available in 5 mg, 10 mg, and 20 mg tablets to treat MDD in adults, but new data from 2 clinical trials using objective measures of cognitive function demonstrated that the drug significantly improved cognitive function, depression, and functionality.

“Cognitive symptoms are often present in patients suffering from MDD and reducing these symptoms can be challenging,” stated John Zajecka, MD, associate professor of psychiatry at Rush University Medical Center in Chicago. “Many patients continue to experience certain cognitive and other symptoms even after improvement in their MDD.”

The FDA has accepted the new clinical data for review and is expected to act on the label addition application by March 28, 2016.

"If approved by the FDA, Brintellix would be the first treatment for MDD to include clinical trial data showing an effect on certain aspects of cognitive function in the US label,” stated Charlie Baum, vice president of US medical affairs at Takeda.