FDA approves Lundbeck, Takeda antidepressant Brintellix

Danish drugmaker Lundbeck has been hiring more than 200 sales reps in the U.S. in anticipation of the FDA approval of the blockbuster antidepressant Brintellix. Well, now they have something to sell. Late Monday, the agency said it had put its stamp of approval on the drug for treating depression.

"Major depressive disorder can be disabling and can keep a person from functioning normally," said Dr. Mitchell Mathis, acting director of the FDA's Division of Psychiatry Products. "Since medications affect everyone differently, it is important to have a variety of treatment options available for patients who suffer from depression."

The FDA said it took its action on data from 6 clinical studies that found Brintellix effective in treating depression and an additional study that found users were less likely to become depressed again after taking Brintellix for their MDD episode. It will come with the usual boxed warning that antidepressants can increase the risk of suicidal thoughts and behavior in children, adolescents and young adults ages 18 to 24 during initial treatment.

Lundbeck CFO Anders Gotzsche figures the drug, to be co-promoted in the U.S. with Japan's Takeda Pharmaceutical, could reach peak sales of $2 billion. Lundbeck needs Brintellix to fill in behind its biggest drug, the antidepressant Cipralex, sold by Forest Laboratories ($FRX) as Lexapro in the U.S. Generics have undermined sales of those products. The approval came even as the company said it would cut another 200 positions in a restructuring it began several months ago in the face of that revenue loss. In its latest quarter, however, it reported that the company's new products grew by 48% for the first half of this year, to 1.4 billion kronor ($253.8 million).

While generic competition is expected to eat away at the depression market through 2022, researchers at Decision Resources expect Brintellix to be one of the most successful new products and project it will hit blockbuster status.

- here's the FDA announcement
- get more from Lundbeck