European CHMP issues positive opinion for a label update of Lundbeck’s Brintellix® (vortioxetine)

Lundbeck today announced that the 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.

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 time¹. Cognitive symptoms encompass a wide variety of signs, including attention and concentration difficulties, problems with thinking speed and difficulty making decisions².

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) study³ in remitted patients with depression. The application, known as a Type II Variation, was submitted to the European Medicines Agency (EMA) in September 2014.

“We are delighted that Brintellix has received this positive opinion from the CHMP, particularly given the role cognitive deficits play in impacting treatment outcomes for many patients” said Anders Gersel Pedersen, Executive Vice President and Head of R&D at Lundbeck. “The encouraging data we have seen on Brintellix when addressing cognitive dysfunction reinforces our belief that Brintellix has the potential to help many patients with their treatment of depression”.

The variation will be implemented upon finalization of the linguistic review process by EMA, expected end of March.

References

1. Conradi HJ et al. Psychol Med 2011
2. European Depression Association, Ipsos Healthcare. IDEA: Impact of Depression at Work in Europe Audit 2012; Biringer E et al. Curr Psychiatry Rev 2009; Hammar Å, Årdal G. Front Hum Neurosci 2009 ; Lee RS et al. J Affect Disord 2012; Marazziti D et al. Eur J Pharmacol 2010 ; Rock PL et al. Psychol Med 2013
3. Positive data from the fMRI study was described in poster presentations at the Annual Meeting of the American College of Neuropsychopharmacology (ACNP) in December 2014 (Browning et al; Dawson et al).