Brintellix (vortioxetine; Lundbeck/Takeda) is the latest antidepressant to be approved in the US for major depressive disorder. The drug follows a successful line of antidepressants developed by Lundbeck, which includes Cipralex (escitalopram) and Cipramil (citalopram). Brintellix was first approved in the US in September 2013 and was made commercially available in January 2014. Launches throughout the EU and other countries have been staggered over 2014–15, while Brintellix remains in Phase III development in Japan.
Brintellix was first discovered by Lundbeck and then co-developed with Takeda, which now markets the drug in the US. Brintellix is a multimodal serotonergic enhancer with activity at the serotonin receptors 5-HT3, 5-HT7, 5-HT1A, and 5-HT1B, and also at the serotonin transporter. This broad pharmacological profile results in an antidepressant activity and also the potential to improve cognitive performance among depressed patients.
Lundbeck and Takeda have developed Brintellix (vortioxetine) primarily as a novel antidepressant with a broad range of serotonergic activities, differentiating the drug from the widely established and generic selective serotonin reuptake inhibitor (SSRI) class. Brintellix’s multimodal mechanism provides it with a robust antidepressant effect, as well as a very competitive tolerability profile. Furthermore, Lundbeck and Takeda have demonstrated a pro-cognitive effect for the drug, which is unique among current antidepressants. The European Medicines Agency (EMA) approved the addition of this benefit to Brintellix’s label, allowing Brintellix to address a common symptom of depression that is commonly overlooked and for which there are no other specific treatment options. Contrary to the EMA’s positive response, the US Food and Drug Administration (FDA) rejected the label expansion, requesting new data before further consideration. The FDA’s negative response not only highlights differences in regulatory agencies’ assessment of clinical data, but will also likely limit Brintellix from reaching its full commercial potential in the US.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Brintellix : Depression LIST OF FIGURES
11 Figure 1: Brintellix for depression – SWOT analysis
12 Figure 2: Datamonitor Healthcare’s drug assessment summary for Brintellix in depression
12 Figure 3: Datamonitor Healthcare’s drug assessment summary for Brintellix in depression
LIST OF TABLES
4 Table 1: Brintellix drug profile
6 Table 2: Brintellix pivotal trial data in depression
Pharma Intelligence UK Limited is a company registered in England and Wales with company number 13787459 whose registered office is Suite 1, 3rd Floor, 11 - 12 St. James's Square, London, England, SW1Y 4LB. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.