
FDA issues CRL for Takeda/Lundbeck’s Brintellix
pharmafile | March 29, 2016 | News story | Manufacturing and Production, Research and Development | Lundbeck, Takeda, brintellix
Takeda and Lundbeck have received a complete response letter from the US Food and Drug Administration (FDA) for the supplemental new drug application to include new data in the clinical trials section of the US label of depression drug 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 drug is believed to work by inhibiting serotonin reuptake.
Takeda and Lundbeck said they were disappointed with the response, as the US FDA Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that the companies had presented substantial evidence to of Brintellix’s efficacy in treating certain aspects of cognitive dysfunction in adults with MDD.
However, the companies were pleased that FDA recognised the importance of cognitive dysfunction in MDD and view it as a legitimate target for drug development.
Joel Levy
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