Eli Lilly and Boehringer Ingelheim were celebrating this morning after winning European clearance for Cymbalta (duloxetine) for the treatment of major depressive episodes.
The announcement had been widely expected after the continent’s advisory panel backed the drug for approval back in September last year [[17/09/04b]]. Cymbalta – known as Xeristar in Greece, Italy and Spain – is already approved in the USA for treating major depression and treating peripheral neuropathy [[05/08/04b]]. It is expected to be a major growth driver for the US company, which is forecasting an 8% to 12% rise in 2005 earnings per share as new products, including Cymbalta, hit the market over the coming months [[10/12/04b]].
Cymbalta is thought to be effective in treating both the emotional (including sadness and anxiety) and somatic symptoms (such as fatigue and pain) of depression due to its dual action on two key neurotransmitters, serotonin and noradrenaline, which are believed to help regulate emotions and sensitivity to pain. The product has been studied in more than 6,000 adults with major depression worldwide, with safety and efficacy demonstrated in four clinical trials and a relapse prevention study.
In Europe alone, the firms estimate that 60 million people suffer from depression – over 40% of whom are not receiving any treatment.
- Meanwhile, Lilly says that it has received the documents allegedly “missing” from a controversial lawsuit over ten years ago linking its Prozac (fluoxetine) antidepressant with suidical attempts and violence, saying that they reveal no new clinical or scientific information.
Last week, the British Medical Journal said that an anonymous source had provided it with the documents, which apparently disappeared during the case in question [[04/01/05c]]. However, Lilly claims that the information contained in the documents has already been shared with the US Food and Drug Administration and other regulatory bodies, published in medical journals or produced through legal discovery and available for use at various legal trials for more than a decade.