New Antidepressant Receives EU Approval

Caroline Cassels

Disclosures

December 30, 2013

The European Commission has granted marketing authorization for vortioxetine (Brintellix, H. Lundbeck A/S) for the treatment of adults with major depression.

The drug's European approval comes on the heels of its approval in the United States in September.

According to a company release, the drug's approval was based on data from 12 short-term, placebo-controlled trials involving 4000 patients with an acute episode of major depression.

In 9 of the 12 studies, Brintellix showed statistically significant and clinically relevant effects on depression relative to placebo. One of these studies was a dedicated study in the elderly. The symptoms of depression were assessed using the Montgomery and Åsberg Depression Scale (MADRS) or the Hamilton Depression Rating Scale (HAM-D24).

The clinical relevance was supported by significant effects observed in the proportions of responders and remitters and in the improvement in the Clinical Global Impression–Global Improvement (CGI-I) score. A dose response was observed, with the efficacy of Brintellix increasing with higher doses, the company reports.

Furthermore, efficacy of Brintellix has also been demonstrated in patients with an acute episode of major depression who had a suboptimal response to treatment with a selective serotonin reuptake inhibitor or a serotonin-norepinephrine reuptake inhibitor.

The recommended starting and treatment dose of Brintellix is 10 mg once daily in adults younger than 65 years. The dose may be increased to a maximum of 20 mg once daily or decreased to a minimum of 5 mg once daily, depending on individual patient response.

"The approval of Brintellix marks yet another step for Lundbeck in a very successful year. With its novel multimodal mechanism of action, we are confident that Brintellix advances both the science and the treatment of a complex and heterogeneous disease consisting of emotional, physical and cognitive symptoms that make it difficult for many patients to achieve full recovery from their disease," executive vice president Anders Gersel Pedersen, head of research and development at Lundbeck, said in a company release.

The approval will be applicable to all 28 European Union member states plus Iceland, Liechtenstein, and Norway. Subject to the completion of pricing and reimbursement discussions, Lundbeck expects to launch Brintellix in its first markets in the second half of 2014.

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