FDA Advisory Committee OKs New Use For Takeda’s, Lundeck’s Antidepressant

The US Food and Drug Administration's (FDA) Psychopharmacologic Drugs Advisory Committee has supported data presented by Takeda Pharmaceutical Company Limited and H. Lundbeck A/S on the effectivness of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). The committee also discussed that cognitive dysfunction in MDD represents an appropriate drug development target.

The advisory committee provides the FDA with independent expert advice and recommendations. The committee's input will be considered by the agency in its review of the Brintellix supplemental new drug application, which was accepted for review in August 2015. The FDA is expected to make a decision by March 28, 2016. The FDA is not bound by the committee’s guidance.

The FDA approved Brintellix on September 30, 2013 for the treatment of MDD in adults. Brintellix is further approved in 64 countries (including Europe, Brazil, Canada, Chile, Mexico, Argentina, South Korea, Turkey, Australia, Hong Kong, Singapore, and South Africa).

Brintellix was discovered by Lundbeck researchers in Copenhagen, Denmark. The clinical trial program in the US was conducted jointly by Lundbeck and Takeda, and Takeda holds the new drug application for the US market. Brintellix is a trademark of H. Lundbeck A/S and is used under license by Takeda Pharmaceuticals U.S.A., Inc.

Brintellix is an inhibitor of serotonin (5-HT) reuptake and that is thought to be a mechanism of its action. It is also an agonist at 5-HT1A receptors, a partial agonist at 5-HT1B receptors and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors. The contribution of each of these activities to Brintellix's antidepressant effect has not been established. It is considered to be the first and only compound with this combination of pharmacodynamic activity.

Source: Takeda Pharmaceutical

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