Drugs Xagena
Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) 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 ), an antidepressant.
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.
The CHMP positive opinion was reached after a review of comprehensive data from the international clinical program comprised of five studies assessing the safety and efficacy of Brintellix including its effect on cognitive performance and function.
The application was based primarily on data from one recently completed clinical study ( CONNECT ) in addition to four clinical studies that were previously submitted as part of the original approval process, as well as a newly completed clinical pharmacology functional magnetic resonance imaging ( fMRI ) study in remitted patients with depression.
The application, known as a Type II Variation, was submitted to the European Medicines Agency in September 2014.
Source: Lundbeck, 2015
XagenaMedicine2015
