Lundbeck’s antidepressant Brintellix will shortly become the first antidepressant approved in the EU to improve cognitive function in patients with depression, after a label update was backed by the CHMP.
The expanded label is based 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.
People suffering from major depression often report a range of cognitive symptoms, including difficulties in thinking clearly, concentration and remembering new information, which can damage self-confidence and contribute to social withdrawal. While cognitive problems are well recognised with other psychiatric disorders such as schizophrenia, their role in depression is less well studied.
“We are delighted that Brintellix has received this positive opinion from the CHMP, particularly given the role cognitive deficits play in impacting treatment outcomes for many patients,” said Lundbeck’s R&D head Anders Gersel Pedersen.
“The encouraging data we have seen on Brintellix when addressing cognitive dysfunction reinforces our belief that Brintellix has the potential to help many patients with their treatment of depression.”
Brintellix (vortioxetine) debuted in the US just over a year ago and is gradually being rolled out across the EU, having been introduced in Lundbeck’s home market – Denmark – last September.
The drug is reported to be the fastest-growing new antidepressant launched in the last three years in the US, where it is co-promoted by Takeda. That is good news for Lundbeck as it needs the new drug to step into the breach left by the expiry of patent protection of its older antidepressant Cipralex (escitalopram oxalate), a former multibillion-dollar blockbuster that has been hit hard by generic competition.
Brintellix added 188m krone ($27m) to Lundbeck’s revenues last year from sales in six EU markets, with 83m of that total coming in the fourth quarter, so it still has some way to go to catch up with Cipralex which remains a 4.6bn krone product despite no longer having market exclusivity.