FDA delays label expansion for Brintellix

The US Food and Drug Administration has issued a complete response letter (CRL) for the supplemental new drug application (sNDA) to include new data in the clinical trials section of the US label of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD).

The FDA approved Brintellix on September 30, 2013 for the treatment of MDD in adults. The CRL does not apply to the use of Brintellix in MDD. The drug was developed by Danish CNS specialist Lundbeck (LUN: CO) and is marketed in the USA by Japan’s Takeda Pharmaceutical (TYO: 4502)

Takeda and Lundbeck say they are disappointed with the response given that the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that Takeda and Lundbeck presented substantial evidence to support a claim of effectiveness for Brintellix in treating certain aspects of cognitive dysfunction in adults with MDD (The Pharma Letter February 4). However, the companies were pleased that FDA recognized the importance of cognitive dysfunction in MDD and view it as a legitimate target for drug development.