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US filing aims to elevate Brintellix above its competition

Drug looking for an edge in the highly competitive major depressive disorder market

Lundbeck HQ 

Lundbeck and Takeda have filed for US approval of new labelling for their antidepressant Brintellix that suggests the drug can improve cognitive function in patients.

The label claim - which was given a green light by the CHMP in Europe earlier this year - will be reviewed by the FDA with a verdict due before March 28 next year, according to a Lundbeck statement.

People suffering from major depression often report a range of cognitive symptoms, including difficulties in thinking clearly, concentration and remembering new information, and a label claim could make Brintellix a strong contender for use in these patients.

The new filing is based in part on the results of the CONNECT trial, which found that Brintellix performed better than Eli Lilly's rival antidepressant Cymbalta (duloxetine) on various cognitive measures when the two drugs were compared to placebo.

A second trial reported in 2013 - called FOCUS - revealed that the drug helped patients be more decisive and think more quickly and clearly compared to placebo.

Lundbeck and Takeda need something to help Brintellix gain headway in the fiercely competitive major depressive disorder (MDD) market, which has become genericised after a string of patent expiries for former blockbusters such as Eli Lilly's Prozac (fluoxetine) and Pfizer's Zoloft (sertraline), as well as newer drugs like Cymbalta.

Brintellix has been on the market in the US since 2013 and has been positioned as a successor to its older antidepressant Cipralex (escitalopram), which was selling around $2bn a year at its peak.

Last year Lundbeck reported Brintellix sales of 188m Danish krone ($28m) last year, somewhat below analyst expectations, although it has been gaining momentum with another 98m krone in sales in the first quarter of 2015. Lundbeck will report its second-quarter results next week.

Meanwhile, Takeda - which has co-promotion rights to the drug in the US - reported fiscal 2015 sales for the drug of 13.6 billion yen ($109m) last month.

Article by
Phil Taylor

12th August 2015

From: Sales

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