Lundbeck wins key FDA backing for expanding depression drug Brintellix's label
- An FDA panel has recommended a label expansion for Lundbeck's antidepressant Brintellix (vortioxtine) to include improvement of cognitive function. Along with Denmark-based Lundbeck, Brintellix is co-marketed by Takeda.
- Lundbeck submitted an sNDA in August 2015 to request inclusion of the cognitive data on the label. The FDA first approved Brintellix for treatment of major depressive disorder (MDD) in 2013.
- According to a three-year prospective study, 94% of people with MDD experience some level of cognitive dysfunction during depressive episodes.
There were high hopes for Brintellix when it was approved two years ago, but sales have disappointed. In 2014, overall sales were $28.4 million, falling short of the $271 million EvaluatePharma predicted for that year. Sales through the first nine months of 2015 have increased significantly from that baseline, but, at about $62 million, remain well off of Lundbeck's blockbuster hopes.
Assuming the FDA does add the cognitive improvement data to the label, it could give Brintellix a competitive edge in the antidepressant market. Drugs like Pifzer's Zoloft or Glaxo's Paxil are well-established, however.
Two eight-week studies demonstrated Brintellix improves thinking, attention, and decision-making ability. A decision from the FDA is expected by March 28, and while the agency is not bound by the committee's recommendations, it usually does follow them.