The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for a label update of H. Lundbeck A/S’s Brintellix® for its effect on certain aspects of cognitive function in patients with depression.
This will be the first summary of the product characteristics of an antidepressant to include an effect on certain aspects of cognitive function in patients with depression in Europe, according to Lundbeck.
The CHMP positive opinion was issued 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, Lundbeck noted. The application, known as a Type II Variation, was submitted to the EMA in September 2014.
This update provides physicians with new Brintellix data related to its effect on certain types of cognitive function and patient functioning in general, as measured by cognitive performance assessment and by functional capacity assessment in patients with major depression, commonly referred to as depression, said Lundbeck in a statement. Patients with depression have cognitive symptoms 94 percent of the time, including attention and concentration difficulties, problems with thinking speed and difficulty making decisions.