Takeda Pharmaceutical Company Limited and H. Lundbeck A/S announced that the U.S. Food and Drug Administration issued a complete response letter or 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) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder or 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.
Takeda and Lundbeck said they 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.
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