Lundbeck shares drop more than 10 percent after FDA decision

COPENHAGEN (Reuters) - Shares in Danish pharmaceutical company Lundbeck fell more than 10 percent on Tuesday after the U.S. Food and Drug Administration (FDA) said it will not add improved cognitive functions to the information leaflet of anti-depressive drug Brintellix.

The decision surprised analysts as the drug had received a recommendation from an FDA committee in February.

"No other drug has shown a benefit on cognition in depression patients and there are no competitor cognition trials ongoing. Assuming eventual approval, this would have provided a clear way for Brintellix to be differentiated and drive sales," Deutsche Bank wrote in a note to clients.

Brintellix, developed with Japan's Takeda <4502.T>, was approved to treat adult depression by U.S. regulators in 2013, and has since been approved in 64 countries.

"This is a big surprise, and it means that Lundbeck here and now will lose some competitive advantages. However, Brintellix still has blockbuster potential," Sydbank analyst Soren Lontoft Hansen told Reuters.

"Takeda and Lundbeck are disappointed with the response given that the (...) committee voted 8 to 2 that Takeda and Lundbeck presented substantial evidence to support a claim of effectiveness for Brintellix in treating certain aspects of cognitive dysfunction in adults with MDD," Lundbeck said in a statement.

At 0945 GMT Lundbeck shares was down 8.9 percent on the Copenhagen bourse.

(Reporting by Annabella Pultz Nielsen; editing by Jason Neely)