Takeda Pharmaceutical Company Limited and H Lundbeck A/S recently stated that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) concerning Brintellix and its supplemental new drug application (sNDA).
Brintellix is the U.S. label from Takeda and Lundbeck. The two companies now have FDA approval for featuring their new data in the clinical trials section of this new product, which is designed to treat specific aspects of adult cognitive dysfunction that is related to major depressive disorder (MDD).
As of Sept. 20, 2013, the FDA granted approval of Brintellix to treat MDD in adult patients. The current CRL does not include using Brintellix for MDD.
The two companies have voiced their disappointment about the CRL, especially since the FDA Psychopharmacologic Drugs Advisory Committee (PDAC) had an 8-2 vote in favor of the substantial evidence that proved Brintellix is effective for specific aspects of cognitive dysfunction in adult MDD.
Despite this, the companies are satisfied that the FDA acknowledged how important it is to remedy the cognitive dysfunction seen in MDD. The officials stated that this is an important target for companies to consider as they develop new drugs for various diseases.
Now, Lundbeck and Takeda plan to evaluate the CRL contents along with officials from the FDA. The outcomes of the evaluation will determine which path the companies take to continue their progress with Brintellix.