Lundbeck Wins U.S. Backing That May Extend Use of Anti-Depressant

By Reuters Staff

February 05, 2016

COPENHAGEN (Reuters) - Denmark's Lundbeck and Japan's Takeda said on Thursday a U.S. Food and Drug Administration (FDA) committee had recommended that its anti-depressant Brintellix (vortioxetine) can add improved cognitive functions to its information leaflet, a first of its kind.

The FDA's Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that there is "substantial evidence" to support the effectiveness of Brintellix for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD), the companies said in a news release.

Though not bound to follow the Committee's recommendation, the FDA is likely to follow it, analysts said. The FDA is expected to make a decision by March 28.

Brintellix, developed with Takeda, was approved to treat adult depression by U.S. regulators in 2013, and has since been approved in 64 countries.

"Lundbeck will be the only product on the market with a leaflet on cognitive effects. FDA is increasing its focus on this area, which means doctors also will," brokerage Alm. Brand wrote in a note to clients.

"Today's positive recommendation underscores the role of addressing the medical need of patients who experience cognitive dysfunction in depression," Emiliangelo Ratti, Senior Vice President, Head of CNS Therapeutic Area Unit, Takeda, said in the release. "Common cognitive symptoms include difficulty concentrating, indecisiveness and trouble thinking. Many of these symptoms are prevalent during major depressive episodes and can have an impact on depressed patients."

Chief Executive Kaare Schultz told Reuters last year he expected Brintellix to become a blockbuster drug that would help the company swing to a profit in 2016.