29 March 2016 - Takeda and Lundbeck today announced that the U.S. FDA 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 U.S. label of Brintellix (vortioxetine hydrobromide) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). The FDA approved Brintellix on 30 September 2013 for the treatment of MDD in adults. The CRL does not apply to the use of Brintellix in MDD.

Takeda and Lundbeck are disappointed with the response given that the U.S. 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. 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.

Takeda and Lundbeck look forward to reviewing the contents of the letter with the FDA to determine the appropriate path forward.

For more details, go to: https://www.lundbeck.com/global