Shutdown looming, FDA approves new depression drug from Lundbeck, Takeda

Regulators at the FDA stamped an approval on Brintellix, a new therapy to treat major depression from Lundbeck and Takeda, just hours before the government prepared to hunker down in a partial shutdown.

Investigators sent their application in with a battery of late-stage results for Brintellix (vortioxetine/Lu AA21004). The Danish company Lundbeck--which has been scrambling to create new drug franchises capable of replacing Lexapro--reported last spring that "out of the ten large, placebo-controlled studies of Lu AA21004 completed in patients with MDD, eight have shown effect of Lu AA21004." The FDA accepted an NDA from Lundbeck and its partner Takeda on Brintellix last December.

It's not easy developing new antidepression drugs, which can be scuttled by unexpected placebo responses. And new therapies remain in high demand among physicians and their patients, who frequently fail a series of treatments before finding one that can be effective.

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

But the news of the approval comes as no surprise to the developers. Lundbeck, which today mapped out cutbacks, said last summer that it would hire 200 reps to market the drug, which company officials believe can earn up to $2 billion a year.

Back in April the companies followed it up with head-to-head data comparing Brintellix with agomelatine, which Servier sells in Europe as Valdoxan. The drug never made it onto the U.S. market. According to investigators, patients taking Brintellix did significantly better on a system for rating depression. The Lundbeck drug groups also did better on secondary endpoints related to anxiety and overall functioning. The patients had all failed to respond to a depression drug.

- here's the FDA release