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Lundbeck sways NICE with new Brintellix data

Final draft guidance now backs the major depressive disorder drug

NICE has recommended Lundbeck's Brintellix for adults with major depressive order in final draft guidance.

The recommendation comes after Lundbeck submitted further evidence for Brintellix (vortioxetine) that NICE had requested in previous draft guidance.

Major depressive disorder is relatively common, affecting an estimated 5-10% of patients in primary care and up to 15% of the elderly.

Professor Carole Longson, director of the centre for health technology evaluation centre at NICE, said: “The committee acknowledged that having access to a range of treatments is important for people with major depressive disorder.

“The committee concluded from this evidence that vortioxetine's effectiveness was comparable with that of other third-line antidepressants and that vortioxetine could be recommended as a cost effective option for treating major depressive episodes in adults who condition has responded inadequately to two antidepressants within the current episode.”

The submission included data from the REVIVE trial which compared Brintellix with Servier's Valdoxan (agomelatine). Results showed Brintellix outperformed Valdoxan and was also much better tolerated by patients with fewer side effects. 

NICE's appraisal committee concluded that the incremental cost-effectiveness ratio compared with other antidepressants was £9,000 per quality adjusted life year gained. It therefore was agreed that treatment with Brintellix was a cost-effective use of NHS resources. 

Earlier this year, Brintellix became the first antidepressant in the EU to improve cognitive function in patients with depression, after a label update was backed by the Committee for Medicinal Products for Human Use (CHMP).

In 2013 Lundbeck partnered with Takeda to promote Brintellix with analysts predicting worldwide sales of $217m and $1.4bn by 2018. 

However, the drug has so far got off to a slow commercial start after its 2014 launch in the US and 11 other countries as sales amounted to just $28.4m in the same year – around a tenth of what had been predicted. 

Article by
Nikhil Patel

19th October 2015

From: Regulatory



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