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Lundbeck buoyed by Brintellix approval in US

FDA gives green light for to Cipralex/Lexapro successor in depression
FDA headquarters White Oak

Lundbeck was celebrating yesterday after the FDA approved its new antidepressant Brintellix, a successor to the big-selling Cipralex/Lexapro brand that lost patent protection in the US last year.

Brintellix (vortioxetine) is one of three products Lundbeck is banking on to drive growth in its business thanks to the impact of generic competition to Cipralex (escitalopram), which has already forced the company to cut jobs and reorganise its business.

The FDA gave the go-ahead for Brintellix to treat adults with major depressive disorder (MDD) on the back of six clinical studies which showed the drug was more effective than placebo in alleviating symptoms, and another trial that found MDD patients were less likely to have symptoms recur after stopping therapy.

Around 15 million people in the US are thought to live with major depression, and Brintellix is expected to do well in the market thanks to its potential for positive effects on cognition and benign side effect profile. Some analysts have predicted worldwide sales could reach $500m in three years and up to $1.5bn at peak.

That is still some way shy of the $2bn plus posted by Cipralex but a solid performance as the market for antidepressants continues to contract thanks to the widespread availability of cheaper generic medicines.

Lundbeck will co-market Brintellix with Takeda in the US, although the Danish drugmaker will sell it on its own in Europe, where it is currently under regulatory review.

It is expected to be prescribed initially as a second-line therapy for patients who do not respond to or cannot tolerate older classes of antidepressant, such as the selective serotonin reuptake inhibitors (SSRIs), but could be used first-line in elderly patients thanks to its tolerability.

Beyond Brintellix, Lundbeck is counting on its once-monthly antipsychotic Abilify (aripiprazole) and alcohol dependency treatment Selincro (nalmefene) to take it back to historical growth rates. Meanwhile, Lundbeck also has two projects in phase III development, namely desmoteplase for ischaemic stroke, which is scheduled for filing in 2014, and Abilify follow-up brexpiprazole.

Article by
Phil Taylor

1st October 2013

From: Sales, Regulatory



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