Ad Comm review positive for Takeda's application for beefed-up label for Brintellix

• The FDA's Psychopharmacologic Drugs Advisory Committee convened on February 3 to discuss cognitive dysfunction in major depressive disorder (MDD) and to review Takeda's (OTCPK:TKPHF)(TKPYY) supplemental New Drug Application (sNDA) seeking to revise the labeling of MDD drug Brintellix (vortioxetine) to include the effect of the drug on certain aspects of cognitive dysfunction in adults with MDD. The committee voted 8 - 2 in favor of approval.
• The agency's action date (PDUFA) is March 28.
• The data supporting the sNDA was primarily generated in two studies, FOCUS and CONNECT, which demonstrated vortioxetine's superiority compared to placebo in improving cognitive function in MDD patients.
• Brintellix was discovered by Lundbeck A/S (OTC:HLUKF) (OTCPK:HLUYY) and was co-developed with Takeda, who holds the NDA in the U.S.
• Previously: Lundbeck and Takeda file sNDA with FDA seeking approval to add cognitive dysfunction data to Brintellix's label (Aug. 11, 2015)