Positive EMA/CHMP opinion for a label update of Brintellix

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for a Type-II Variation related to the update of the European summary of the product characteristics (SmPC) for Brintellix (vortioxetine), from Danish CNS drug specialist Lundbeck (LUN: CO).

Brintellix was first launched in Europe last fall (in Denmark) and in the USA at the beginning of 2014. Deutsche Bank analyst Tim Race said Brintellix could generate sales in excess of $1.5 billion and possibly up to $3 billion a year. Lundbeck’s shares rose 2.9% to 135.80 Danish kroner in morning trading today.

The update of the SmPC provides physicians with new Brintellix data related to its effect on certain aspects of cognitive function and patient functioning in general, as measured by cognitive performance assessment (neuropsychological test such as Digit Symbol Substitution Test (DSST)) and by functional capacity assessment (University of San Diego Performance-Based Skills Assessment (UPSA)) in patients with major depression, commonly referred to as depression. Patients with depression have cognitive symptoms 94% of the time. Cognitive symptoms encompass a wide variety of signs, including attention and concentration difficulties, problems with thinking speed and difficulty making decisions.