In reversal, FDA denies cognitive dysfunction label expansion for Brintellix
- In a complete response letter, the FDA this week denied an expanded indication for the antidepressant Brintellix, co-marketed by Lundbeck and Takeda. Despite a recommendation from an FDA advisory committee, the agency declined to add new data to Brintellix's label supporting use of the drug for treatment of cognitive dysfunction in adults with depression.
- In early February, the advisory committee had voted 8 to 2 in favor of adding the new data.
- Takeda and Lundbeck both expressed disappointment in the FDA's decision but plan to continue discussions with the agency on next steps. Lundbeck's stock
- While Takeda and Lundbeck expressed disappointment with the FDA's decision, the companies plan to continue discussions with the FDA to determine next steps. Lundbeck's stock slumped in Copenhagen trading as investors digested the potential ramifications on Brintellix's sales forecasts.
This rejection is unusual as the FDA typically follows the recommendation of the relevant advisory committee. However, the response from Lundbeck and Takeda suggests the FDA views cognitive dysfunction in depression as a area worth exploring.
“Takeda and Lundbeck are disappointed with the response. However, the companies were pleased that FDA recognized the importance of cognitive dysfunction in MDD and view it as a legitimate target for drug development," the companies said in a joint statement.
Lundbeck and Takeda had submitted phase 3 data from two eight-week, randomized, placebo-controlled clinical trials in which adults with major depressive disorder (MDD) received 10 mg or 20 mg doses of Brintellix. Cognitive function was measured with the Digit Symbol Substitution Test, a validated tool commonly used in psychiatry.
Depression can lead to decreased cognitive functioning, especially in cases of severe depression. In a three-year prospective study of people being treated for depression, cognitive symptoms were reported 94% of the time in severe depression and 44% of the time during remission.
The CRL from the FDA does not impact the MDD indication for which Brintellix is approved in 64 countries.