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EMA backs Lundbeck's Brintellix in depression

Drug recommended for approval to treat major depressive episodes in adults
Lundbeck HQ

In the latest round of EU drug recommendations, Lundbeck won backing for the use of Brintellix in the treatment of adult patients with major depressive episodes.

The Committee for Medicinal Products for Human Use (CHMP) – the body to advise the European Medicines Agency (EMA) - recommended marketing authorisation for the drug, which was approved in the US for the same indication last month.

The EU recommendation is another important step for Denmark-based Lundbeck as it looks to overcome the patent expiration of its big-selling antidepressant Lexapro (escitalopram oxalate).

This has led to major cutbacks in the company, including a restructure of its European business and the loss of hundreds of jobs.

The CHMP opinion is based on data from a clinical trial programme that included more than 7,000 patients.

More than 4,000 patients with depression were treated with Brintellix (vortioxetine) in 12 short-term (6 to 8 weeks), placebo-controlled studies of major depressive disorder.

In 9 of the 12 studies, data demonstrated that Brintellix was able to improve the effects of depression compared to placebo.

Lundbeck also provided data from a trial which compared Brintellix to Servier's Valdoxan (agomelatine) - the most recently approved antidepressant in the EU.

According to Lundbeck, this trial demonstrated that Brintellix was significantly superior to Valdoxan based on certain depression symptom scales.

The drug works by its ability to inhibit the serotonin (5-HT) transporter, causing an antidepressant effect.

A final EU approval is expected within three months and Lundbeck said it expects that Brintellix will be available in its first European markets during the first half of 2014.

Article by
Thomas Meek

28th October 2013

From: Regulatory

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