Please login to the form below

Not currently logged in
Email:
Password:

Lundbeck and Takeda submit depression drug for US approval

Brintellix could help Lundbeck overcome loss of patent protection for Lexapro/Cipralex

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.

13th December 2012

From: Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Solaris Health

The beauty of detail: an effective, compelling medical communications campaign requires each component to be carefully planned, expertly crafted and...

Latest intelligence

ema1
The European Medicines Agency: PRIME’d for access?
Leela Barham examines the impact of the EMA's PRIME fast track system after two years...
How can pharma engage with key stakeholders on NHS service transformation?
Steve How, Paul Midgley and Oli Hudson, of the Wilmington Healthcare consulting team, explain how pharma should make its case for change...
michael elliot
The race for an HIV ‘cure’
Supercharging therapies as pharma and patients work together...

Infographics