Lundbeck wins U.S.
backing that may extend use of anti-depressant
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[February 04, 2016]
COPENHAGEN (Reuters) - Denmark's
Lundbeck said on Thursday a U.S. Food and Drug Administration (FDA)
committee had recommended that its anti-depression drug Brintellix can
add improved cognitive functions to its information leaflet, a first of
Though not bound to follow the Committee's recommendation, the FDA
is likely to follow it, analysts said.
"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
Brintellix, developed with Japan's Takeda, was approved to treat
adult depression by U.S. regulators in 2013, and has since been
approved in 64 countries.
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.
The FDA is expected to make a decision by March 28.
By 0826 GMT (3.26 p.m. EDT) shares in Lundbeck traded 10.3 percent
higher for the day, while the benchmark Copenhagen index OMXC20CAP
was up 1.1 percent.
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(Reporting by Annabella Pultz Nielsen, editing by Terje Solsvik)
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