Lundbeck’s plans to find a replacement for its big-selling antidepressant Lexapro/Cipralex continue with the company submitting Brintellix for US approval.
The treatment, which is to be co-marketed by Takeda in the US, will be reviewed by the Food and Drug Administration (FDA) for use against major depressive disorder (MDD) in adults.
Some 15 million people in the US are estimated to live with major depression and the filing is a positive step for Lundbeck as it prepares to cope with generic competition to Lexapro/Cipralex, sales of which dropped 9 per cent in the third quarter of 2012 following loss of patent protection.
The development of Brintellix (vortioxetine) is already for paying off for the company, however, with Lundbeck receiving a milestone payment of $50m from Takeda as part of a co-commercialisation agreement signed in September 2007 for several compounds in Lundbeck’s pipeline.
The drug is also under review by the European Medicines Agency in Europe, where Lundbeck is due to market the drug without a partner if it is approved.
Lundbeck said Brintellix, which was formerly known as Lu AA21004, works as a serotonin 5-HT3 and 5-HT7 receptor antagonist, and 5-HT1b receptor partial agonist, and 5-HT1a receptor agonist and an inhibitor of the serotonin transporter.
Both US and European marketing applications contain data from several studies that have demonstrated Brintellix enhances the levels of eurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine, all of which are implicated in depression.
The target date of complete for the application review in the US is October 2, 2013.