First melatonergic antidepressant receives EU CHMP positive opinion

The first melatonergic antidepressant Valdoxan/Thymanax (agomelatine) has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for its use in the treatment of adult patients with major depressive disorder (MDD).

Upon approval by the European Commission in early 2009, Valdoxan is expected to be marketed by Servier in European countries in the following months.

Valdoxan is a new approach to the treatment of MDD, and has proven efficacy across a wide range of patients, including the most severely depressed.

It compares favourably with the most currently-prescribed antidepressants and offers new hope to the 33 million people in Europe who suffer from MDD, a disease for which there is still a significant medical need for improved management of patients’ depressive symptoms.