Cymbalta gets Europe go-ahead
marketing authorisation by the European Commission. The new therapy
is said to be able to treat the full spectrum of depressive
symptoms.
Eli Lilly and Boehringer Ingelheim's dual action drug gives it a relatively unique profile among marketed drugs, and is expected to present strong competition to Wyeth's Effexor(venlafaxine). Cymbalta (duloxetine) is a balanced reuptake inhibitor of serotonin and noradrenaline and is effective in treating the emotional and somatic symptoms of depression due to its action on these two key neurotransmitters.
In Europe alone, an estimated 60 million people suffer from depression. More than 40 per cent of those fail to receive any treatment and only 25-35 per cent of patients treated for depression in clinical studies experience remission.
The approval of Cymbalta in the European Union is a major step forward in giving healthcare professionals and patients in all major European countries a long-awaited efficient and well-tolerated new option. The final approval had been widely expected after a positive recommendation from a committee of European scientific experts in September. It has already been approved by the US Food and Drug Administration last year.
The drug is expected to present a strong challenge to the market position of Effexor (venlafaxine), which has been established in Europe since 1995. However the lack of data comparing Cymbalta with Effexor should favour the latter.
Such is the potency of selective serotonin reuptake inhibitors that guidelines were introduced recommending its use and dosage. In December 2004, the UK's National Institute of Clinical Excellence (NICE) and the Medicine and Healthcare Products Regulatory Agency (MHRA) announced restricted prescribing of selective serotonin reuptake inhibitors, and recommended Effexor be prescribed only by specialist psychiatrists.
