FDAnews
www.fdanews.com/articles/175253-adcomm-recommends-brintellix-for-cognitive-dysfunction

Adcomm Recommends Brintellix for Cognitive Dysfunction

February 9, 2016

The FDA’s Psychopharmacologic Drugs Advisory Committee voted 8 to 2 to support a new claim for Takeda’s Brintellix for the treatment of cognitive dysfunction in major depressive disorder.

Patients treated with Brintellix had statistically significantly greater improvement than those in the placebo group in a cognitive test. The FDA said that while there is a general idea of what the test, known as the Digital Symbol Substitution Test, measures, the agency discussed whether those results were clinically meaningful. The drug is approved for the treatment of MDD in the U.S. and Europe.

Noting that the data for Brintellix are better than placebo in treating cognitive dysfunction, one committee member said that information belongs on the label.

Others, however, were not as convinced. Natalie Compagni Portis, a patient representative from Oakland, Calif., voted no, describing the DSST as an incomplete measure, noting it doesn’t take several things into account, such as processing speed.

A large part of the discussion focused on whether cognitive impairment in MDD is a suitable drug development target. Panelists also assessed how cognitive function can be measured as an endpoint. The general consensus was that cognitive dysfunction is an appropriate target even if it is difficult to quantify.